INDICATIONS, SAFETY, AND WARNINGS Protege RX Carotid 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

Indications: The Protégé™ RX carotid stent system, when used in conjunction with the ev3 embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet the following criteria: 1. Patients with carotid artery stenosis (≥ 50% for symptomatic patients by ultrasound or angiography or ≥ 80% for asymptomatic patients by ultrasound or angiography) of the Common or Internal Carotid Artery, AND 2. Patients must have a reference vessel diameter within the range of 4.5 mm and 9.5 mm at the target lesion.

Contraindications: Use of the Protégé RX carotid stent system is contraindicated under these circumstances: Patients in whom anticoagulant, antiplatelet therapy or thrombolytic drugs is contraindicated; patients with vascular tortuosity or anatomy, which precludes the safe introduction of the sheath, guide catheter, embolic protection system, or stent system; patients with known hypersensitivity to nickel-titanium; patients with uncorrected bleeding disorders; lesions in the ostium of the common carotid artery.

WARNING: Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid interventional procedures should use this device

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 closure, Allergic reactions to procedural medications, contrast dye or device materials, Amaurosis fugax, Aneurysm, Angina/coronary ischemia, Arrhythmia, Arterial occlusion or thrombosis at puncture site or remote site, Arteriovenous fistula, Bacteremia or septicemia, Bleeding from anticoagulant or antiplatelet medications, Bleeding, with or without transfusion, Cerebral edema, Cerebral hemorrhage, Cerebral ischemia or transient ischemic attack (TIA), Congestive heart failure (CHF), Death, Detachment of a component of the device system, Embolism (air, tissue, thrombus), Emergent or urgent endarterectomy surgery (CEA), Fever, Filter thrombosis or occlusion, Fluid overload, Groin hematoma, with or without surgical repair, Hemorrhage, with or without transfusion, Hyperperfusion syndrome, Hypotension or hypertension. Infection and/or pain at the puncture site, Ischemia or infarction of tissue/organ, Myocardial infarction (MI), Pain (head, neck), Pseudoaneurysm, femoral, Renal failure/insufficiency (new or worsening), Restenosis of stented segment, Seizure, Severe unilateral headache, Slow/no flow during procedure, Stent/filter collapse or fracture, Stent/filter entanglement or damage, Stent/filter failure to deploy, Stent embolization, migration or misplacement, Stent or vessel thrombosis/occlusion, Stroke/cerebrovascular accident (CVA), Total occlusion of carotid artery, Vessel dissection, flap, perforation, or rupture,Vessel spasm or recoil.

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 this device to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

FTSOP113326-39 Rev. 1A