400U23

Indications, Safety, and WarningsImportant labeling information for the United StatesIndicationsThe Avalus Ultra™ bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.ContraindicationsNone known.Warnings/Precautions/Adverse EventsOnly physicians who have received proper training in valve replacement should use this device. As with any implanted medical device, there is potential for patient immunological response, including an allergic response. Care should be exercised in patients with hypersensitivities to the device materials. Calcific degeneration could cause accelerated deterioration of the valve in patients with altered calcium metabolism (for example, chronic renal failure, hyperparathyroidism). Calcification may occur earlier in children, adolescents, or young adults. Premature calcification may also occur in older adults who accept a biologic prosthesis. Patients with a bioprosthesis that require chronic anticoagulation are at additional risk of bleeding. Stenosis and regurgitation of the bioprosthesis may occur in patients with coagulation disorders such as AT3 deficiency. Paravalvular leak is more likely to occur in patients with aneurysmal aortic or degenerative conditions, cystic medial necrosis, or Marfan syndrome. Adverse events can include: angina, aortic tissue damage, cardiac dysrhythmias, embolism, endocarditis, heart failure, hemolysis, hemolytic anemia, anticoagulant/antiplatelet-related hemorrhage, immunological response (including allergic response), inflammatory reaction, infection other than endocarditis, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction (leaflet entrapment/impingement, obstructive pannus ingrowth, suture dehiscence, inappropriate sizing), pericardial effusion, pleural effusion, prosthesis regurgitation, prosthesis stenosis, stroke, structural deterioration (calcification, leaflet tear), tamponade, or valve thrombosis. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability or organ damage, or death.Caution: Federal law (USA) restricts this device 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.US-CV-2500471 v1.0

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