310CJ31

Indications, Safety, and WarningsIndications for useFor the replacement of malfunctioning native or prosthetic mitral heart valves.ContraindicationsNone known.Warnings, precautions, and adverse eventsAccelerated 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 can include angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, infection other than endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis.Caution: Federal law (United States) restricts this device to sale by or on the order of a physician.For a list of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the instructions for use. For countries that use (electronic instructions for use) eIFUs, consult instructions for use at this website medtronic.com/manuals.UC202502343 EN

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