T505U229

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Indications, Safety, and WarningsIndications for use These valves are for patients who require replacement of their native or prosthetic aortic and/or mitral valves.Contraindications None known. Warnings, precautions, adverse events Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events potentially associated with the use of bioprosthetic heart valves include angina, cardiac arrhythmia, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage (anticoagulant/antiplatelet related), leak (transvalvular or paravalvular), myocardial infarction nonstructural dysfunction (obstructive pannus ingrowth, suture dehiscence, inappropriate sizing, other), stroke, structural deterioration (calcification, leaflet tear, other) thromboembolism, valve thrombosis. It is possible that these complications could lead to reoperation, explanation, permanent disability, and death.Additional adverse events can include angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis.For additional information, please refer to the instructions for use provided with the product.Caution: Federal law (United States) restricts this device to sale by or on the order of a physician.UC202410321 EN

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