Solitaire™ X Revascularization Device
Indications 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.
Cautions
- Caution: Federal (USA) law restricts this device to sale distribution and use by or on order of a physician. Indications, contraindications, warnings and instructions for use can be viewed at medtronic.com/manuals.
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.
React™ Catheter
Indications for use
The React™ 68 Catheter and React™ 71 Catheter are indicated for the introduction of interventional/diagnostic devices into the peripheral and neurovasculature.
The React™ 68 Catheter and React™ 71 Catheter are also indicated for the removal/aspiration of emboli and thrombi from selected blood vessels in the arterial system, including the neurovasculature.
Precautions
- Do not use open, kinked, or damaged devices.
- Do not autoclave.
- Use the catheter in conjunction with fluoroscopic visualization.
- Inspect the catheter before use to verify that its size and condition are suitable for the specific procedure.
- Do not advance or withdraw the catheter against resistance without careful assessment of the cause using fluoroscopy. If the cause cannot be determined, withdraw the device. Moving or torqueing the device against resistance may result in damage to the vessel or device.
- Maintain a constant infusion of appropriate flush solution.
- If flow through the catheter becomes restricted, do not attempt to clear the lumen by infusion. Remove and replace the device.
- Extreme care must be taken to avoid damage to the vasculature through which the catheter passes. The catheter may occlude smaller vessels. Care must be taken to avoid complete blood flow blockage.
- Torqueing the catheter may cause damage which could result in kinking and possible separation along the catheter shaft. Should the catheter become severely kinked, withdraw the catheter.
- An appropriate anticoagulation therapy should be applied per institutional guidelines.
- Operators should 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.
Contraindications
There are no known contraindications.
Compatibility
Refer to product label for device dimensions. Refer to labeling provided with other medical technologies to determine compatibility.
Potential complications
Possible complications include, but are not limited to, the following:
- Acute occlusion
- Allergic reaction and anaphylaxis from contrast media
- Complication at puncture site
- Complication of radiation exposure (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia)
- Embolism
- False aneurysm formation
- Infection
- Inflammation
- Intracranial hemorrhage
- Ischemia
- Neurological deficits including stroke
- Vessel spasm, thrombosis, dissection or perforation
Warnings
- The catheter should only be used by physicians who have received appropriate training in interventional techniques.
- Do not reuse. The device is intended for single use only. Discard the catheter after one procedure. Structural integrity and/or function may be impaired through reuse or cleaning. Catheters are extremely difficult to clean after exposure to biological materials and may cause adverse patient reactions if reused.
- 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.
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events.
Phenom™ Catheter
Indications for use
Phenom™ Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.
Caution
Do not attempt to use catheters without flushing or hydrating first with saline. Failure to do so, may compromise the coating and lubricity of the catheter.
Precautions
- This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
- Inspect the catheter prior to use for any kinks or bends. Any catheter damage may decrease the desired performance characteristics.
- Do not use if package is open or damaged. Contents of unopened, undamaged package are sterile.
- Use prior to the “use by” date.
- Carefully read all instructions prior to use. Failure to observe all warnings and precautions may result in complications.
Contraindications
None known.
Potential complications
Potential complications include, but are not limited to, the following:
- Distal emboli (air, foreign material, tissue or thrombus)
- Hematoma
- Hemorrhage
- Infection
- Ischemia
- Pain at insertion site
- Neurological deficit that could lead to stroke and death
- Vessel spasm, dissection, perforation or injury
Warnings
- 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 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 intralumenal 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 flowrate charts (see IFU).
- 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.