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CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR PROPERLY LICENSED PRACTITIONER. St. Jude Medical Stented Tissue Valves are indicated for use as a replacement for malfunctioning native or prosthetic aortic and/or mitral valves. Adverse events potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage (anticoagulant/antiplatelet-related), leak (transvalvular or paravalvular), myocardial infarction, nonstructural dysfunction (e.g. pannus, suture, inappropriate sizing, or other), prosthesis regurgitation, stroke, structural deterioration (e.g. calcification, leaflet tear, or other), thromboembolism and valve thrombosis. It is possible that these complications could lead to: reoperation, explantation, permanent disability, or death. Long-term anticoagulation and/or anti-platelet therapy should be considered in patients with dilated left atrium, a history of thrombotic events, or a cardiac rhythm of atrial fibrillation or flutter. Please see the Instructions for Use (IFU) for a full description of indications, contraindications, side effects, precautions, warnings, and Instructions for Use.

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