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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H10: additional manufacturer narrative: updated sections: b4, g3, g6, h2, h6 (investigation findings, and investigation conclusions).Engineering evaluation summary: based on the information available, the device was intentionally used outside the way it was designed and intended.The performance, safety, efficacy, longevity, and durability of rings and bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.Per technical summary 33069, rev.A, regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration.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, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Per technical summary 31081, rev.A, 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.The most likely cause is patient factors, including implant position, patient's age at time of event and the congenital heart defects.All pertinent information available to edwards lifesciences has been submitted.
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It was reported that a model 11500a 23mm pericardial valve in the pulmonic position was disabled via a valve-in-valve procedure after an implant duration of 3 years, 2 months due to severe pulmonary insufficiency, mild pvl, poor leaflet coaptation, and severe rv dilation.A 9600tfx 26mm transcatheter valve was successfully implanted via a hybrid sub xiphoid process.Patient was transferred to cv intermediate post procedure.
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