Health & lifestyle risk factors for stroke

See package insert for complete indications, complications, warnings, and instructions for use.

INDICATIONS FOR USE

1. The Trevo Retriever 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 start within 6 hours of symptom onset.
2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
3. The Trevo Retriever 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 (0-50cc for age < 80 years, 0-20cc for age ≥ 80 years). Endovascular therapy with the device should start within 6-24 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.

COMPLICATIONS

Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with possible complications which may occur during or after the procedure. Possible complications include, but are not limited to, the following: air embolism; hematoma or hemorrhage at puncture site; infection; distal embolization; pain/headache; vessel spasm, thrombosis, dissection, or perforation; emboli; acute occlusion; ischemia; intracranial hemorrhage; false aneurysm formation; neurological deficits including stroke; and death.

COMPATIBILITY

3x20mm retrievers are compatible with Trevo® Pro 14 Microcatheters (REF 90231) and Trevo® Pro 18 Microcatheters (REF 90238). 4x20mm retrievers are compatible with Trevo® Pro 18 Microcatheters (REF 90238). 4x30mm retrievers are compatible with Excelsior® XT-27® Microcatheters (150cm x 6cm straight REF 275081) and Trevo® Pro 18 Microcatheters (REF 90238). 6x25mm Retrievers are compatible with Excelsior® XT-27® Microcatheters (150cm x 6cm straight REF 275081). Recommended minimum vessel ID for all Retriever sizes is 2.5mm. Compatibility of the Retriever with other microcatheters has not been established. Performance of the Retriever device may be impacted if a different microcatheter is used. Balloon Guide Catheters (such as Merci® Balloon Guide Catheter and FlowGate® Balloon Guide Catheter) are recommended for use during thrombus removal procedures. Retrievers are compatible with the Abbott Vascular DOC® Guide Wire Extension (REF 22260). Retrievers are compatible with Boston Scientfic Rotating Hemostatic Valve (Ref 421242).

SPECIFIC WARNINGS FOR INDICATION 1

• The safety and effectiveness of the Trevo Retrievers in reducing disability has not been established in patients with large core infarcts (i.e. ASPECTS ≤ 7). There may be increased risks, such as intracerebral hemorrhage, in these patients.
• The safety and effectiveness of the Trevo Retrievers in reducing disability has not been established or evaluated in patients with occlusions in the posterior circulation (e.g., basilar or vertebral arteries) or for more distal occlusions in the anterior circulation.

SPECIFIC WARNINGS FOR INDICATION 2

• To reduce risk of vessel damage, take care to appropriately size Retriever to vessel diameter at intended site of deployment.

SPECIFIC WARNINGS FOR INDICATION 3

• The safety of effectiveness of the Trevo Retrievers in reducing disability has not been established in patients with large core infarcts (i.e. ASPECTS ≤ 7). There may be increased risks, such as intracerebral hemorrhage, in these patients.
• The safety and effectiveness of the Trevo Retrievers in reducing disability has not been established or evaluated in patients with occlusions in the posterior circulation (e.g. basilar or vertebral arteries) or for more distal occlusions in the anterior circulation.
• Users should validate their imaging software analysis techniques to ensure robust and consistent results for assessing core infarct size.

WARNING APPLIED TO ALL INDICATIONS

• Administration of IV t-PA should be within the FDA - approved window (within 3 hours of stroke symptom onset).
• To reduce risk of vessel damage, adhere to the following recommendations:
• To not perform more than six (6) retrieval attempt in same vessel using Retriever devices.
• Maintain Retriever position in vessel when removing or exchanging Microcatheter.
• To reduce risk of kinking/fracture, adhere to the following recommendations:
• Immediately after unsheathing Retriever, position Microcatheter tip marker just proximal to shaped section. Maintain Microcatheter tip marker just proximal to shaped section of Retriever during manipulation and withdrawal.
• Do not rotate or torque Retriever.
• Use caution when passing Retriever through stented arteries.
• The Retriever is a delicate instrument and should be handled carefully. Before use and when possible during procedure, inspect device carefully for damage. Do not use a device that shows signs of damage. Damage may prevent device from functioning and may cause complications.
• Do not advance or withdraw Retriever against resistance or significant vasospasm. Moving or torquing device against resistance or significant vasospasm may result in damage to vessel or device. Assess cause of resistance using fluoroscopy and if needed resheath the device to withdraw.
• If Retriever is difficult to withdraw from the vessel, do not torque Retriever. Advance Microcatheter distally, gently pull Retriever back into Microcatheter, and remove Retriever and Microcatheter as a unit. If undue resistance is met when withdrawing the Retriever into the Microcatheter, consider extending the Retriever using the Abbott Vascular DOC guidewire extension (REF 22260) so that the Microcatheter can be exchanged for a larger diameter catheter such as a DACR Catheter. Gently withdraw the Retriever into the larger diameter catheter.
• Administer anti-coagulation and anti-platelet medications per standard institutional guidelines.
• Users 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.

PRECAUTIONS

• Prescription only - device restricted to use by or on order of a physician.
• Store in cool, dry, dark place.
• Do not use open or damaged packages.
• Use by “Use By” date.
• Exposure to temperatures above 54° (103° F) may damage device and accessories. Do not autoclave.
• Do not expose Retriever to solvents.
• Use Retriever in conjunction with fluoroscopic visualization and proper anti-coagulation agents.
• To prevent thrombus formation and contrast media crystal formation, maintain a constant infusion of appropriate flush solution between guide catheter and Microcatheter and between Microcatheter and Retriever or guidewire.
• Do not attach a torque device to the shaped proximal end of DOC® Compatible Retriever. Damage may occur, preventing ability to attach DOC® Guide Wire Extension.

Stryker Neurovascular
4790 Bayside Parkway
Fremont, CA 94538
strykerneurovascular.com
Date of Release: SEP/2016
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