INDICATIONS, SAFETY, AND WARNINGS EverFlex Self-expanding Peripheral Stent

Note: Safety information provided is for the United States.  Please refer to your region’s Instructions for Use for specific details.

This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call Medtronic at (877) 526-7890. Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions. 


BRIEF STATEMENT

Indication: The EverFlex™ self-expanding peripheral stent system is intended to improve luminal diameter in the treatment of symptamotic de novo or restenotic lesions up to 180 mm in length in the native superficial femoral artery and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 mm – 7.5 mm.

The EverFlex self-expanding peripheral stent system is indicated for improving luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries up to and including 100 mm in length, with a reference vessel diameter of 4.5 mm - 7.5 mm.

The Protégé™ EverFlex self-expanding biliary stent system is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Contraindications: Use of the EverFlex self-expanding peripheral stent system is contraindicated in patients with known hypersensitivity to nickel titanium and in patients contraindicated for anticoagulant and/or antiplatelet therapy, patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system.

Potential Adverse Events: Potential adverse events which may be associated with the use of a stent in the SFA and proximal popliteal arteries include, but are not limited to: Allergic reaction, Amputation, Artery perforation or rupture, Bleeding requiring transfusion, Infection, Pseudoaneurysm, Restenosis, Stent collapse or fracture, Stent migration, Surgical or endovascular intervention, Thrombosis/occlusion of the stent.

See the Instructions for Use provided with the product for a complete list of warnings, precautions, adverse events and device information.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.

FTSOP113326-40 Rev. 1A