It was reported that a patient with a 21mm 11500a valve underwent a valve-in-valve procedure after an implant duration of four (4) years, seven (7) months, due to severe symptomatic aortic stenosis and reduced motion of valve.The tavr was successfully performed with a 23mm 9755rsl transcatheter valve.Patient was in recovery post procedure.Per medical records, the patient is 32-year-old with past medical history significant for three (3) open heart surgeries which resulted from iv drug use.Patient presented with shortness of breath, recurrent lightheadedness, near syncope.Patient reported loc in shower.Tavr was successfully performed with 23mm 96755rsl transcatheter valve.Ttvr with a 26mm sapien ultra resilia transcatheter valve was also successfully performed during the procedure.
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The device was not returned to edwards for evaluation as it remains implanted.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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Leaflet immobility or leaflet restriction occurring over time, and not due to extrinsic physical interference, is a form of structural valve deterioration, which can result in significant regurgitation and/or stenosis.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.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.
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