INDICATIONS, SAFETY, AND WARNINGS
RIST™ RADIAL ACCESS SYSTEM
The Rist™ Radial Access Selective Catheter
Rist™ 071 Radial Access Guide Catheter
Rist™ 079 Radial Access Guide Catheter
INDICATIONS FOR USE
The Rist™ Radial Access Selective Catheter is indicated for the introduction of interventional devices into the peripheral, coronary and neurovasculature. It can be used to facilitate introduction of diagnostic agents in the neurovasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.
The Rist™ 071 & 079 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neurovasculature.
CAUTION
Federal (USA) law restricts this device to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use for the Rist™ 079 Radial Access Guide Catheter ad Rist™ Radial Access Selective Catheter can be found at www.medtronic.com/manuals.
WARNINGS
For Rist™ 071 Radial Access Guide Catheter
- Visually inspect all sterile barrier systems, that are labeled as sterile, immediately prior to use. Do not use the device if breaches in the sterile barrier system integrity are evident.
- Carefully inspect the device packaging prior to use. Do not use if package appears open or damaged or if any of its components is missing. If damage is found, call your Medtronic representative.
- This device is intended for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
- When the Guide Catheter is introduced to the vascular system, it should be manipulated while under high- quality fluoroscopic observation. Do not advance or retract the Guide Catheter if resistance is met during manipulation; determine the cause of the resistance before proceeding.
- Torquing or moving the device against resistance may result in damage to the vessel or device.
- This device is coated with a hydrophilic coating at the distal end of the device for a length of 25 cm. Please refer to the Preparation for Use for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this Instructions for Use may result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
For Rist™ 079 Radial Access Guide Catheter
- Contents supplied sterile using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Medtronic Neurovascular representative.
- Do not use if labeling is incomplete or illegible.
- For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
- When the Guide Catheter is introduced to the vascular system, it should be manipulated while under high- quality fluoroscopic observation. Do not advance or retract the Guide Catheter if resistance is met during manipulation; determine the cause of the resistance before proceeding.
- Torquing or moving the device against resistance may result in damage to the vessel or device.
- This device is coated with a hydrophilic coating at the distal end of the device for a length of 25cm. Please refer to the preparation and directions sections for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this labeling may result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
- After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
For Radial Access Selective Catheter
- Contents supplied sterile using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged.
- Carefully inspect the device packaging prior to use. Do not use if package appears open or damaged or if any of its components is missing. If damage is found, call your Medtronic Neurovascular representative.
- For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
- The safety and effectiveness of this device for radial neurovasculature access in direct comparison to a transfemoral approach has not been demonstrated. The risks and benefits for radial access against a transfemoral approach should be carefully weighed and considered for each patient.
- Appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice.
- Sufficient shielding, reduced fluoroscopy times, and modified X-ray technical factors should be used when possible to limit patient and physician exposure to X-ray radiation doses.
PRECAUTION
For Rist™ 071 Radial Access Guide Catheter
- Use the device prior to the “Use By” date specified on the package.
- Maintain a constant infusion of appropriate flush solution.
- If flow through the device becomes restricted, do not attempt to clear the lumen by infusion. Remove and replace the device.
- Examine the device to verify functionality and to ensure that its size and shape are suitable for the specific procedure for which it is to be used.
- This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures.
- Prior to beginning radial artery access, conduct screening, such as an Allen test, to ensure that radial access is appropriate for the patient.
- For other devices and fluids not supplied within this package but used in conjunction with this product, please refer to their respective Instructions for Use.
- Operators should take all necessary precautions to limit X-ray radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors whenever possible.
- Avoid wiping the device with dry gauze as this may damage the device coating.
- Avoid excessive wiping of the coated device.
- Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating which could affect the device safety and performance.
- Use an appropriate hemostasis valve during the procedure.
For Rist™ 079 Radial Access Guide Catheter
- The Rist™ 079 Radial Access Guide Catheter must only be used by physicians trained in intravascular intervention.
- Use the device prior to the “Use By” date specified on the package.
- Maintain a constant infusion of appropriate flush solution.
- If flow through the device becomes restricted, do not attempt to clear the lumen by infusion. Remove and replace the device.
- Examine the device to verify functionality and to ensure that its size and shape are suitable for the specific procedure for which it is to be used.
- The Rist™ 079 Radial Access Guide Catheter should be used only by physicians trained in percutaneous procedures and/or interventional techniques.
- Prior to beginning radial artery access, perform an assessment of the collateral circulation of the hand to ensure that radial access is appropriate for the patient.
- Limit the exposure to X-ray radiation doses to patients and physicians by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors when possible.
- Avoid wiping the device with dry gauze as this may damage the device coating.
- Avoid excessive wiping of the coated device.
- Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating which could affect the device safety and performance.
- Use an appropriate hemostasis valve during the procedure.
For Rist™ Radial Access Selective Catheter
- The Rist™ Radial Access Selective Catheter must only be used by physicians trained in intravascular intervention
- This product is supplied sterile using an ethylene oxide (EO) process.
- Use the device only prior to the “Use By” date listed on the package label.
- The Rist™ Radial Access Selective Catheter is designed to be used under high-quality fluoroscopic observation.
- When the catheter is introduced to the vascular system, it should be manipulated while under high quality fluoroscopic observation. Do not advance or retract the catheter if resistance is met during manipulation; determine the cause of the resistance before proceeding.
- Do not advance the guide catheter or long sheath over the Rist™ Radial Access Selective Catheter while forming the shape. Doing so may cause Rist™ Radial Access Selective Catheter to kink.
- Do not apply excessive torque or rotation to the system.
- The Rist™ Radial Access Selective Catheter should not be used as a dilator for sheathless insertion of a long sheath.
- Maintain a constant infusion of appropriate flush solution.
- All agents to be infused must be used according to the manufacturer’s instructions for use.
- The maximum permissible pressure for the Rist™ Radial Access Selective Catheter is 600psi (4136 kPa). Do not exceed the maximum permissible injection pressure as it may damage the device or injure the patient. See table below for pressures and flow rates for catheter use in diagnostic procedures. Flowrates were determined using a 50/50 mixture of Saline/Omnipaque 300 at 23°C using the 130cm working length catheter.
- Table 1. Diagnostic Catheter Pressure at Common Flow Rates
- Flowrate (mL/s) 4 6 8 10
- Pressure (PSI) 100 203 341 501
- Pressure (kPa) 689 1400 2351 3454
- If flow through the catheter becomes restricted, remove and replace the device. Do not attempt to clear the catheter lumen by flushing it.
- Flush the entire device with heparinized saline prior to placement to avoid accidental introduction of air into the system.
- Prior to beginning radial artery access, perform an assessment of the collateral circulation of the hand to ensure that radial access is appropriate for the patient.
POTENTIAL COMPLICATIONS
For Rist™ 071 Radial Access Guide Catheter
Potential complications of the device and the endovascular procedure include or are synonymous with, but may not be limited to:
- Access site complications, including sterile inflammation or granulomas
- Air Embolism
- Allergic Reaction, including anaphylaxis from contrast media and contrast media related risks (e.g., kidney damage)
- Death
- Embolism
- False Aneurysm Formation
- Fistula
- Hemorrhage
- Hypersensitivity
- Hypotension
- Infection
- Inflammation
- Intracranial hemorrhage
- Ischemia
- Material Left in Patient
- Neurological deficit/ dysfunction
- Occlusion
- Organ failure
- Pain And Tenderness
- Pathological Hand Cold Intolerance
- Radial Artery Occlusion
- Stenosis
- Stroke/ Cerebral infarction
- Therapeutic response decreased
- Thromboembolism
- Thrombus/ Thrombosis
- Vessel Collapse
- Vessel Dissection
- Vessel Perforation or Rupture
- Vessel Spasm/ Vasoconstriction
- Vision symptoms
- Hand Dysfunction
- Complications of radiation exposure such as alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia
- Tissue necrosis
For Rist™ 079 Radial Access Catheter & Rist™ Radial Access Selective
- Air Embolism
- Allergic Reaction
- Death
- Embolism
- False Aneurysm Formation
- Fistula
- Hemorrhage
- Hypersensitivity
- Hypotension
- Infection
- Inflammation
- Intracranial hemorrhage
- Ischemia
- Material Left in Patient
- Neurological deficit/ dysfunction
- Occlusion
- Organ failure
- Pain And Tenderness
- Radial Artery Occlusion
- Stenosis
- Stroke/ Cerebral infarction
- Therapeutic response decreased
- Thromboembolism
- Thrombus/ Thrombosis
- Vessel Collapse
- Vessel Dissection
- Vessel Perforation or Rupture
- Vessel Spasm/ Vasoconstriction
- Vision symptoms
Pipeline™ Flex Embolization Device with Shield Technology™
INDICATIONS FOR USE
The Pipeline™ Flex Embolization Device with Shield Technology™ is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. The Pipeline™ Flex Embolization Device with Shield Technology™ is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width ≥ 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm.
CAUTION
Federal (USA) law restricts this device to sale, distribution and use by or on the order of a physician. Indications, contraindications, warnings and instructions for use for the Pipeline™ Flex Embolization Device with Shield Technology™ can be viewed at https://www.medtronic.com/manuals.
CONTRAINDICATIONS
- Patients with active bacterial infection.
- Patients in whom dual antiplatelet and/or anticoagulation therapy (aspirin and clopidogrel) is contra-indicated.
- Patients who have not received dual antiplatelet agents prior to the procedure.
- Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location.
- Patients in whom the parent vessel size does not fall within the indicated range.
WARNINGS
- Pushing delivery wire without retracting the micro catheter at the same time will cause the open end braid to move distally in the vessel. This may cause damage to the braid or vessel.
- Use in tortuous anatomy may result in difficulty or inability to deploy the Pipeline™ Flex Embolization Device with Shield Technology™ and can lead to damage to the Pipeline™ Flex Embolization Device with Shield Technology™ and microcatheter. To mitigate potential problems as a result of increased delivery forces, reduce the load in the system by: Unloading the microcatheter to the inner curves of vessel by pulling back on the system (i.e., the microcatheter and delivery wire together). Continue unloading the system until advancement of the device (inside the microcatheter) is observed, while minimizing the distal tip movement prevent loss of position. Begin to re-advance the delivery wire while maintaining reduced load in the microcatheter. This process should be repeated until the device passes through tortuous area and the delivery force is decreased.
- Resheathing the Pipeline™ Flex Embolization Device with Shield Technology™ more than 2 full cycles may cause damage to the distal or proximal ends of the braid.
- Persons with known allergy to platinum or cobalt/chromium alloy (including the major elements platinum, cobalt, chromium, nickel, molybdenum or tungsten) may suffer an allergic reaction to the Pipeline™ Flex Embolization Device with Shield Technology™ implant.
- Person with known allergy to tin, silver, stainless steel, or silicone elastomer may suffer an allergic reaction to the Pipeline™ Flex Embolization Device with Shield Technology™ delivery system.
- Do not reprocess or resterilize. Reprocessing and resterilization increase the risk of patient infection and compromised device performance.
- Post-procedural movement (migration and/or foreshortening) of the Pipeline™ Flex Embolization Device with Shield Technology™ implant may occur following implantation and can result in serious adverse events and/or death.
- Factors which may contribute to post procedural device movement include (but are not limited to) the following: Failure to adequately size the implant (I.e., under sizing), Failure to obtain adequate wall apposition during the implant deployment, Implant stretching, Vasospasm, Severe vessel tapering, Tortuous anatomy.
- Delayed rupture may occur with large and giant aneurysms.
- Placement of multiple Pipeline™ Flex Embolization Device with Shield Technology™ may increase the risk of ischemic complications.
- Use in anatomy with severe tortuosity, stenosis or parent vessel narrowing may result in difficulty or inability to deploy the Pipeline™ Flex Embolization Device with Shield Technology™ and can lead to damage to the Pipeline™ Flex Embolization Device with Shield Technology™ and microcatheter. Advancement or retraction of the Pipeline™ Flex Embolization Device with Shield Technology™ against resistance may result in damage, including unintended device or component separation, fracture, or breakage of the delivery system due to inherent flexibility limits of device design. Device damage may result in patient injury or death. Refer to page 4 in the instructions for use for additional information.
- Do not attempt to reposition the device after full deployment.
- The benefits may not outweigh the risks of treatment of small and medium asymptomatic extradural intracranial aneurysms, including those located in the cavernous internal carotid artery. The risk of rupture for small and medium asymptomatic extradural intracranial aneurysms is very low if not negligible.
- A decrease in the proportion of patients who achieve complete aneurysm occlusion without significant parent artery stenosis has been observed with the use of the device in the communicating segment (C7) of the internal carotid artery (47.4% (9/19 subjects in the PREMIER study at 1 year)), including those IAs fed by the posterior circulation or have retrograde filling. Ensure appropriate patient selection and weigh the benefits and risks of alternative treatments prior to use of this device for the treatment of intracranial aneurysms located in this region of the ICA. The following anatomical characteristics, associated with retrograde filling, should be carefully considered during procedural planning of C7 intracranial aneurysms: PComm of fetal origin (A PCA of fetal origin is defined as a small, hypoplastic, or absent P1 segment of the PCA with the PComm artery supplying a majority of blood flow to the ICA); PComm overlapping with the aneurysm neck; and/or PComm branch arising from the dome of the aneurysm.
- The safety and effectiveness of this device for radial neurovasculature access in direct comparison to a transfemoral approach has not been demonstrated. The risks and benefits for radial access against a transfemoral approach should be carefully weighed and considered for each patient.
PRECAUTIONS
- The Pipeline™ Flex Embolization Device with Shield Technology™ should be used only by physicians trained in percutaneous, intravascular techniques, and procedures at medical facilities with the appropriate fluoroscopy equipment.
- Physicians should undergo appropriate training prior to using the Pipeline™ Flex Embolization Device with Shield Technology™ in patients.
- The Pipeline™ Flex Embolization Device with Shield Technology™ is intended for single use only. Store in a cool, dry place. Carefully inspect the sterile package and device components prior to use to verify that they have not been damaged during shipping. Do not use kinked or damaged components. Do not use product if the sterile package is damaged.
- Use the Pipeline™ Flex Embolization Device with Shield Technology™ system prior to the “Use By” date printed on the package.
- The appropriate anti-platelet and anti- coagulation therapy should be administered in accordance with standard medical practice.
- A thrombosing aneurysm may aggravate pre-existing, or cause new, symptoms of mass effect and may require medical therapy.
- Use of implants with labeled diameter larger than the parent vessel diameter may result in decreased effectiveness and additional safety risk due to incomplete foreshortening resulting in an implant longer than anticipated.
- The Pipeline™ Flex Embolization Device with Shield Technology™ may create local field inhomogeneity and susceptibility artifacts during magnetic resonance angiography (MRA), which may degrade the diagnostic quality to assess effective intracranial aneurysm treatment.
- Take all necessary precautions to limit X-radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors where possible.
- Carefully weigh the benefits of treatment vs. the risks associated with treatment using the device for each individual patient based on their medical health status and risks factors for intracranial aneurysm rupture during their expected life time such as age, medical comorbidities, history of smoking, intracranial aneurysm size, location, and morphology, family history, history of prior asymptomatic subarachnoid hemorrhage (aSAH), documented growth of intracranial aneurysm on serial imaging, presence of multiple intracranial aneurysms, and presence of concurrent pathology. The benefits of device use may not outweigh the risks associated with the device in certain patients; therefore, judicious patient selection is recommended.
- The safety and effectiveness of the device has not been established for treatment of fusiform IAs.
- There may be a decrease in effectiveness and increase in safety events when the device is used in patients ≥ 60 years old.
- The safety and effectiveness of the device has not been evaluated or demonstrated for ruptured aneurysms.
- If using radial artery access, perform a screening examination of the radial artery per institutional practices to ensure that radial access is appropriate for the patient.
POTENTIAL COMPLICATIONS
Potential complications of the device and the endovascular procedure include, but are not limited to, the following:
- Access site complications like hematoma, inflammation, infection, necrosis, pain and tenderness, granuloma
- Adverse reaction to anti-platelet/anticoagulation agents, anesthesia, reactions due to radiation exposure (such as alopecia, burns ranging in severity from skin reddening to ulcers, cataracts and delayed neoplasia) or contrast media, including organ failure
- Vascular Complications like vasospasm, stenosis, dissection, perforation, rupture, fistula formation, pseudo aneurysm, occlusion, thromboembolic complications including ischemia (to unintended territory)
- Device complications like fracture, breakage (including unintended device or component separation), misplacement, migration/delayed foreshortening or reaction to device materials may occur
- Systemic complications like: Infection, Pain, fever, allergic reactions, organ failure, nerve damage
- Bleeding/hemorrhagic complication including retroperitoneal hemorrhage
- Neurological Deficits or dysfunctions including Stroke, Infarction, Loss of vision, Seizures, TIA, Headache, Cranial Nerve Palsies, Confusion, Coma, Hand Dysfunction
- Decreased therapeutic response including need for target aneurysm retreatment
- Risks associated with visual symptoms include Amaurosis Fugax/transient blindness, Blindness, Diplopia, Reduced visual acuity/field, Retinal artery occlusion, Retinal ischemia, Retinal infarction, Vision impairment including scintillations, blurred vision, eye floaters
- Intra-Cranial Hemorrhage (including from Aneurysm Rupture) Brain Edema, Hydrocephalus, Mass Effect
- Death
Indications, contraindications, warnings and instructions for use for the Pipeline™ Flex Embolization Device with Shield Technology™ can be viewed at https://www.medtronic.com/manuals.
Axium™ and Axium™ Prime Detachable Coils
Federal (USA) law restricts this device to sale, distribution, and use by or on the order of a physician. This device should be used only by physicians with a thorough understanding of angiography and percutaneous neurointerventional procedures.
See Instructions for Use for a complete list of warnings, precautions, and contraindications.
INDICATIONS
Axium™ and Axium™ Prime detachable coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ and Axium™ Prime detachable coils are also intended for the embolization of other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Axium™ Prime Detachable Coil (Frame): The Axium™ Prime detachable coil system is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Prime detachable coils are also indicated for arterial and venous embolizations in the peripheral vasculature.
POTENTIAL COMPLICATIONS
Potential complications include, but are not limited to:
- Puncture site hematoma
- Vessel perforation
- Vasospasm
- Hemorrhage
- Thromboembolic episodes
- Neurological deficits including stroke and death
- Vascular thrombosis
- Ischemia
WARNINGS
- The Axium™ or Axium™ Prime Detachable Coil, the dispenser track, and the introducer sheath are supplied in a sterile and nonpyrogenic, unopened and undamaged package. The package should be checked for potential damage. Damaged Axium™ and Axium™ Prime Detachable Coils must not be used, as they may result in patient injury.
- The AXIUM™ PRIME Detachable Coil, the dispenser track, and the introducer sheath are supplied in a sterile and non-pyrogenic, unopened and undamaged package. The package should be checked for potential damage. Damaged AXIUM™ PRIME Detachable Coils must not be used, as they may result in patient injury.
- The Axium™ and Axium™ Prime Detachable Coils are intended for one use only. The Axium™ I.D. (Instant Detacher) is supplied sterile and intended for single patient use. After use do not resterilize and/or reuse. Reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which in turn, may result in patient injury, illness or death.
- Do not use if sterile packaging has been compromised or damaged.
- Damaged implant delivery pusher and/or coils may affect coil delivery to, and stability inside, the vessel or aneurysm, possibly resulting in coil migration or stretching.
- Do not rotate the implant delivery pusher during or after delivery of the coil into the aneurysm. Rotating the delivery pusher during or after coil delivery into the aneurysm may result in a stretched coil or premature detachment of the coil from the implant delivery pusher, which could result in coil migration.
- Do not use hemostats in an attempt to advance delivery pusher. This may result in a kinked pusher which may lead to premature detachment.
- Verify that the distal shaft of the microcatheter is not under stress before the Axium™ or Axium™ Prime Detachable Coil detachment. Axial compression or tensile forces could be stored in the microcatheter causing the tip to move during the Axium™ or Axium™ Prime Detachable Coil delivery. Microcatheter tip movement could cause the aneurysm or vessel to rupture.
- Advancing the delivery pusher beyond the microcatheter tip once the coil has been deployed and detached involves risk of aneurysm or vessel perforation.
- If undesirable movement of the Axium™ or Axium™ Detachable Coil can be seen under fluoroscopy following coil placement and prior to detachment, remove the coil and replace with another more appropriately sized Axium™ or Axium™ Prime Detachable Coil. Movement of the coil may indicate the coil could migrate once it is detached. Angiographic controls should also be performed prior to detachment to ensure that the coil mass is not protruding into the parent vessel.
- High quality, digital subtraction fluoroscopic road mapping is mandatory to achieve safe catheterization of the aneurysm or vessel and correct placement of the first coil. With smaller aneurysms this is a particularly important step.
- If Axium™ or Axium™ Prime Detachable Coil repositioning is necessary, take special care to retract coil under fluoroscopy in a one-to-one motion with the implant pusher. If the coil does not move with a one-to-one motion, or repositioning is difficult, the coil has been stretched and could possibly break. Gently remove and discard both the catheter and coil.
- Due to the delicate nature of the Axium™ and Axium™ Prime Detachable Coil, the tortuous vascular pathways that lead to certain aneurysms and vessels, and the varying morphologies of intracranial aneurysms, a coil may occasionally stretch while being maneuvered. Stretching is a precursor to potential malfunctions such as coil breakage and migration.
- If resistance is encountered while withdrawing an Axium™ or Axium™ Prime Detachable Coil, which is at an acute angle relative to the catheter tip, it is possible to avoid coil stretching or breaking by carefully repositioning the distal tip of the catheter at the ostium of the aneurysm, or just slightly inside the parent artery.
- Take care not to puncture gloves or sterile drape while handling implant delivery pusher.
- Multiple placements of Axium™ or Axium™ Prime Detachable Coils may be required to achieve the desired occlusion of some aneurysms or vessels.
- The long term effect of this product on extravascular tissues has not been established so care should be taken to retain this device in the intravascular space.
- This device is supplied STERILE for single use only. Do not reprocess or re-sterilize. Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance.
- Do not use hemostats in an attempt to advance delivery pusher. This may result in a kinked pusher which may lead to premature detachment.
- If attempt to detach fails, remove coil from treatment area and microcatheter and replace with a new AXIUM™ PRIME Detachable Coil.
- If coil becomes prematurely detached, remove implant pusher and:
- Advance next coil to push remaining tail of prematurely detached coil into treatment area
- Remove prematurely
- Do not resterilize the AXIUM™ I.D. (Instant Detacher). For Single Patient use only.
- The AXIUM™ I.D. (Instant Detacher) is intended for a maximum of 25 cycles.
- The Axium™ or Axium™ Prime Detachable Coil, the dispenser track, and the introducer sheath are supplied in a sterile and nonpyrogenic, unopened and undamaged package. The package should be checked for potential damage. Damaged Axium™ and Axium™ Prime Detachable Coils must not be used, as they may result in patient injury.
- The AXIUM™ PRIME Detachable Coil, the dispenser track, and the introducer sheath are supplied in a sterile and non-pyrogenic, unopened and undamaged package. The package should be checked for potential damage. Damaged AXIUM™ PRIME Detachable Coils must not be used, as they may result in patient injury.
- The Axium™ and Axium™ Prime Detachable Coils are intended for one use only. The Axium™ I.D. (Instant Detacher) is supplied sterile and intended for single patient use. After use do not resterilize and/or reuse. Reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which in turn, may result in patient injury, illness or death.
- Do not use if sterile packaging has been compromised or damaged.
- Damaged implant delivery pusher and/or coils may affect coil delivery to, and stability inside, the vessel or aneurysm, possibly resulting in coil migration or stretching.
- Do not rotate the implant delivery pusher during or after delivery of the coil into the aneurysm. Rotating the delivery pusher during or after coil delivery into the aneurysm may result in a stretched coil or premature detachment of the coil from the implant delivery pusher, which could result in coil migration.
- Do not use hemostats in an attempt to advance delivery pusher. This may result in a kinked pusher which may lead to premature detachment.
- Verify that the distal shaft of the microcatheter is not under stress before the Axium™ or Axium™ Prime Detachable Coil detachment. Axial compression or tensile forces could be stored in the microcatheter causing the tip to move during the Axium™ or Axium™ Prime Detachable Coil delivery. Microcatheter tip movement could cause the aneurysm or vessel to rupture.
- Advancing the delivery pusher beyond the microcatheter tip once the coil has been deployed and detached involves risk of aneurysm or vessel perforation.
- If undesirable movement of the Axium™ or Axium™ Detachable Coil can be seen under fluoroscopy following coil placement and prior to detachment, remove the coil and replace with another more appropriately sized Axium™ or Axium™ Prime Detachable Coil. Movement of the coil may indicate the coil could migrate once it is detached. Angiographic controls should also be performed prior to detachment to ensure that the coil mass is not protruding into the parent vessel.
- High quality, digital subtraction fluoroscopic road mapping is mandatory to achieve safe catheterization of the aneurysm or vessel and correct placement of the first coil. With smaller aneurysms this is a particularly important step.
- If Axium™ or Axium™ Prime Detachable Coil repositioning is necessary, take special care to retract coil under fluoroscopy in a one-to-one motion with the implant pusher. If the coil does not move with a one-to-one motion, or repositioning is difficult, the coil has been stretched and could possibly break. Gently remove and discard both the catheter and coil.
- Due to the delicate nature of the Axium™ and Axium™ Prime Detachable Coil, the tortuous vascular pathways that lead to certain aneurysms and vessels, and the varying morphologies of intracranial aneurysms, a coil may occasionally stretch while being maneuvered. Stretching is a precursor to potential malfunctions such as coil breakage and migration.
- If resistance is encountered while withdrawing an Axium™ or Axium™ Prime Detachable Coil, which is at an acute angle relative to the catheter tip, it is possible to avoid coil stretching or breaking by carefully repositioning the distal tip of the catheter at the ostium of the aneurysm, or just slightly inside the parent artery.
- Take care not to puncture gloves or sterile drape while handling implant delivery pusher.
- Multiple placements of Axium™ or Axium™ Prime Detachable Coils may be required to achieve the desired occlusion of some aneurysms or vessels.
- The long term effect of this product on extravascular tissues has not been established so care should be taken to retain this device in the intravascular space.
- This device is supplied STERILE for single use only. Do not reprocess or re-sterilize. Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance.
- Do not use hemostats in an attempt to advance delivery pusher. This may result in a kinked pusher which may lead to premature detachment.
- a. If attempt to detach fails, remove coil from treatment area and microcatheter and replace with a new AXIUM™ PRIME Detachable Coil.
- b. If coil becomes prematurely detached, remove implant pusher and:
- i. Advance next coil to push remaining tail of prematurely detached coil into treatment area
- ii. Remove prematurely
- Do not resterilize the AXIUM™ I.D. (Instant Detacher). For Single Patient use only.
- The AXIUM™ I.D. (Instant Detacher) is intended for a maximum of 25 cycles.
