INDICATIONS, SAFETY, AND WARNINGS Protégé GPS Self-expanding Peripheral and Biliary 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 Protégé™ GPS™ self-expanding peripheral stent systems 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 reference vessel diameters of 7.5 – 11 mm.

The stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Contraindications: Use of the Protégé GPS self-expanding peripheral stent system is contraindicated in patients with known hypersensitivity to nickel titanium; patients contraindicated for anticoagulant and/or antiplatelet therapy; patients who 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 common and/or external iliac arteries include, but are not limited to: Abrupt or sub-acute closure, Allergic reaction to device materials or procedure medications, Allergic reaction to Nitinol, Amputation, Aneurysm, Angina, Arrhythmia, Arterio-venous fistula, Artery injury (e.g., dissection, perforation, or rupture), Bleeding requiring transfusion, Bruising, Contrast medium reaction/renal Failure, Death, Device breakage, Edema, Embolism, Failure to deploy stent, Fever, Gastrointestinal bleeding due to Anticoagulation, Hematoma, Hypertension/Hypotension, Infection, Inflammation, Intraluminal thrombus, Myocardial infarction Pain, Partial stent deployment, Pseudoaneurysm, Renal failure, Renal insufficiency, Restenosis, Sepsis, Shock, Stent collapse or fracture, Stent migration, Stent misplacement, Stroke, Surgical or endovascular Intervention, Thrombosis/occlusion of the stent, Transient ischemic attack, Venous thromboembolism, Vessel spasm, Worsening claudication or rest, pain.

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

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

FTSOP113326-38 Rev. 1A