H10: additional manufacturer narrative: the subject device is not available for evaluation as it remains implanted in the patient.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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Edwards received notification that this 31 year old patient with a 11500a25 valve implanted in pulmonic position underwent a valve-in-valve procedure after an implant duration of one (1) year and one (1) month due to degeneration leading to severe stenosis and important regurgitation (maximum gradient at admission 93mmhg and average of 56mmhg, final gradient 10mmhg, maximum speed of 4.8m/s, transprosthetic reflux quantitative parameter suggestive of important (pht 101ms)).As reported patient presented with dyspnea, tiredness and loss of ventricular function.A 29mm transcatheter valve was successfully implanted within the pre-existing surgical device.Reportedly, the patient was noted as to be discharged home on post operative day 2.
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Updated section b4 (date of this report), g3 (date received by manufacturer), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).H10: additional manufacturer narrative: the serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Degeneration-related structural deterioration is most commonly related to patient factors and is not usually an indication of a device malfunction related to a manufacturing deficiency.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed, including implant position.
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