Additional information: d10 h3, h6.Explant was reported due to infective endocarditis and endocarditis of the valve prosthesis.The investigation found that the mechanical leaflets opened and closed completely and easily.There was minimal pannus formation on the sewing cuff.In addition to the valve, separate fragments of myocardium were also received, which had areas of necrosis.No inflammation or significant areas of calcification were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined.
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