SERB65-09-60-80

Protégé™ GPS™ self-expanding peripheral and biliary stent system shown in a u-shape

Indications, Safety, and WarningsNote: Safety information provided is for the United States. 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. Prior to use, refer to the instructions for use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions. IndicationsThe Protégé™ GPS™ self-expanding peripheral biliary 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 reference vessel diameters of 7.5 mm to 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 biliary 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, precautions, adverse events, and device information. Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician. FTSOP113326-38 Rev. 1A

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