FR995-27

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Indications, Safety, and WarningsIndications for use The Freestyle bioprosthesis is indicated for the replacement of malfunctioning native or prosthetic aortic valves with the option, for Model 995 only, of aortic root replacement. Contraindications None known.Warnings, precautions, and 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 can include: cardiac dysrhythmias, death, endocarditis, hemolysis, anticoagulant/antiplatelet-related hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction (pannus, suture, inappropriate sizing, or other), structural deterioration (calcification, leaflet tear, intracuspal hematoma, pseudoaneurysm (Model 995), or other), thromboembolism, valve thrombosis, root dilatation (Model 995), angina, infection other than endocarditis, heart failure, hemolytic anemia, myocardial infarction, acute kidney injury, or renal failure. It is possible that these complications could lead to reoperation, explantation, permanent disability, or death. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (IFU). If applicable, consult electronic IFUs (eIFUs) at www.medtronic.com/manuals. Note: eIFUs can be viewed using a current version of any major internet browser. US-CV-2500585 v1.0

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