Indications for use
The APRO™* 70 catheter with an aspiration pump and the Alembic™* aspiration tubing is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV tPA) or who fail IV t-PA therapy are candidates for treatment.
The Alembic™* aspiration tubing is intended to connect the APRO™* 70 catheter to the aspiration pump.
Contraindications
There are no known contraindications.
Cautions
Rx Only: Federal (USA) law restricts this device to sale by or on the order of a physician.
- Do not use if the pouch is opened or damaged.
- This device is intended for single use only. Do not reuse, reprocess, or re-sterilize. Reuse, reprocessing or re-sterilization may compromise the structural integrity of the device and/or lead to device failure, which may result in patient injury, illness, or death. Reuse, reprocessing, or re-sterilization 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.
- After use, dispose of the device in accordance with hospital and/or local government policy.
Warnings
- The APRO™* 70 catheter should only be used by physicians who have received appropriate training in interventional techniques and treatment of acute ischemic stroke.
- The APRO™* 70 catheter is provided sterile and non-pyrogenic. Do not use if the packaging is breached or damaged.
- Extreme caution should be used if it is required that APRO™* be advanced near or through any aneurysms or other vascular malformations.
- Do not wedge the tip of the APRO™* 70 catheter in the vessel, as this may result in perforation or dissection of the vessel wall.
- Excessive aspiration with the distal tip of the APRO™* 70 catheter covered by the vessel wall may cause vessel injury. Carefully investigate the location of the distal tip under fluoroscopy prior to aspiration.
- Do not attempt to clear the inner lumen of the APRO™* 70 catheter by infusion while keeping the device in the patient. When the flow from the lumen stops or becomes stagnant during aspiration, do not attempt to clear the inner lumen of the APRO™* 70 catheter by infusion while keeping the device in the patient. Remove the APRO™* 70 catheter from the patient before attempting to clear the lumen.
- For additional Materials of Concern information, such as REACH, CA Prop 65, or other product stewardship programs, go to medtronic.com/productstewardship.
Solitaire™ X revascularization device
Indication for use
- The Solitaire™ X revascularization device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
- The Solitaire™ X revascularization device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.
- The Solitaire™ X revascularization device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (<70 cc by CTA or MRA, <25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
Caution
- Federal (USA) law restricts this device to sale by or on the order of a physician.
Precautions
The Solitaire™ X revascularization device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.
- 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.
- Carefully inspect the sterile package and the Solitaire™ X revascularization device prior to use to verify that neither has been damaged during shipment. Do not use kinked or damaged components.
- The Solitaire™ X revascularization device is not to be used after the expiration date imprinted on the product label.
- Refer to the appropriate intravenous tissue plasminogen activator (IV t-PA) manufacturer labeling for indications, contraindications, warnings, precautions, and instructions for use.
- Initiate mechanical thrombectomy treatment as soon as possible.
- For indication 3, endovascular therapy with the device should be started within 16 hours of symptom onset.
- For indication 3, users should validate their imaging analysis techniques to ensure robust and consistent results for assessing core infarct size.
Contraindications
Use of the Solitaire™ X revascularization device is contraindicated under these circumstances.
- Patients with known hypersensitivity to nickel-titanium.
- Patients with stenosis and/or pre-existing stent proximal to the thrombus site that may preclude safe recovery of the Solitaire™ X revascularization device.
- Patients with angiographic evidence of carotid dissection.
Potential complications
Possible complications include, but are not limited to the following:
- Adverse reaction to antiplatelet/anticoagulation agents or contrast media
- Air embolism
- Allergic reactions
- Angina
- Arrhythmia
- Arteriovenous fistula
- Aspiration
- Brain edema
- Cancer
- Change in mental status
- Coagulopathy
- Death
- Device(s) deformation, collapse, fracture or malfunction
- Distal embolization including to a previously uninvolved territory
- Embolism
- Fever
- Fistula
- Foreign body in patient
- Foreign body reaction
- Hemolysis
- Hemorrhage
- Hemorrhagic stroke
- Hypersensitivity
- Hypertension
- Hypotension
- Infarction, cerebral
- Infection
- Inflammation
- Ischemia
- Myocardial Infarction
- Necrosis
- Nerve damage
- Neurologic deterioration including stroke progression, stroke in new vascular territory, and death
- Organ failure
- Pain
- Perforation or dissection of the vessel
- Persistent neurological deficits
- Radiation exposure, unintended
- Rupture
- Shock
- Stenosis
- The risk of complication of radiation exposure (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia) increases as the procedure time and the number of procedures increase
- Therapeutic response decreased
- Thromboembolism
- Thrombosis (acute and subacute)
- Toxicity
- User experiences major dissatisfaction with device performance
- Vascular occlusion
- Vasoconstriction (Vasospasm)
- Vision symptoms
Warnings — all indications
- The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice.
- Administer IV t-PA as soon as possible for all patients who are indicated to receive the drug. Do not cause delays in this therapy.
- Per IV t-PA manufacturer labeling, IV t-PA should be administered within 3 hours of stroke symptom onset. (IV t-PA use beyond 3 hours is not approved in the United States.)
- Do not torque the Solitaire™ X revascularization device.
- For vessel safety, do not perform more than three recovery attempts in the same vessel using Solitaire™ X revascularization devices.
- For device safety, do not use each Solitaire™ X revascularization device for more than three flow restoration recoveries.
- For each new Solitaire™ X revascularization device, use a new microcatheter.
- Solitaire™ X revascularization device does not allow for electrolytic detachment.
- To prevent device separation:
- Do not oversize device.
- Do not recover (i.e., pull back) the device when encountering excessive resistance. Instead, resheath the device with the microcatheter and then, remove the entire system under aspiration. If resistance is encountered during resheathing, discontinue and remove the entire system under aspiration.
- Do not treat patients with known stenosis proximal to the thrombus site.
- 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.
- If excessive resistance is encountered during the delivery of the Solitaire™ X revascularization device, discontinue the delivery and identify the cause of the resistance. Advancement of the Solitaire™ X revascularizaton device against resistance may result in device damage and/or patient injury.
- If excessive resistance is encountered during recovery of the Solitaire™ X revascularization device, discontinue the recovery and identify the cause of the resistance.
- Advancing the microcatheter while the device is engaged in clot may lead to embolization of debris.
- Do not advance the microcatheter against any resistance.
- Do not reposition more than two times.
Warnings — indication 1 and 3 only
- The safety and effectiveness has not been established for the Solitaire™ X device to reduce disability in patients with the following:
- Posterior circulation occlusions
- More distal occlusions in the anterior circulation
- Large core infarct (ASPECTS ≤7)
Disclaimer: This page may include information about products that may not be available in your region or country. Please consult the approved indications for use. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use.
Phenom™ catheter
Indications for use
Phenom™ catheters are intended for the introduction of interventional devices or diagnostic agents into the neuro, peripheral, and coronary vasculatures.
Caution
- 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 trained in percutaneous, intravascular techniques and procedures.
Potential Complications
Potential complications of the devices and the endovascular procedure include or are synonymous with, but may not be limited to the following:
- Pain at insertion site
- Hematoma
- Hemorrhage
- Infection
- Sensitization or an allergic reaction
- Complication of radiation exposure (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia)
- Distal emboli (air, foreign material or thrombus)
- Vessel spasm, dissection, perforation or injury
- Ischemia
- Stroke that could lead to Neurological deficit and death
*Consult instructions for use for other therapy devices and medications for additional potential complication information. If a serious incident related to the device occurs, contact your Medtronic representative and the competent authority in your respective country/region.
Contraindictions
There are no known contraindictions
Warning
- THIS DEVICE IS INTENDED FOR SINGLE USE ONLY. Discard after one procedure. Reuse and/or re-sterilization can potentially result in compromised device performance and cross contamination.
- The Phenom™ catheter should be manipulated under fluoroscopy only. Do not attempt to move the catheter without observing the resultant tip response.
- Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the catheter against resistance may result in damage to the catheter, or the vessel.
- The infusion pressure should not exceed the listed pressure as indicated in flow rate table (listed in IFU).
- Nickel (CAS 7440-02-0) is present in the Phenom™ catheter and may cause sensitization or an allergic reaction.
- The catheter has not been tested for use with automated high-pressure contrast injection equipment, do not use this equipment with the device because it may damage the device.
- Visually inspect all sterile barrier systems, that are labeled as sterile, immediately prior to use. Do not use the device if breaches in sterile barrier system integrity are evident.
- For additional materials of concerns information such as REACH, CA Prop 65 or other product stewardship programs, go to medtronic.com/productstewardship.
- Do not use catheters that are damaged in any way. Damaged catheters may break or rupture causing vessel damage or tip detachment during the procedure.
- Shaping mandrel is not for in-vivo use.
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events.
™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.