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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It was reported that a patient with a 19mm 11500aj aortic valve underwent a valve-in-valve procedure after an implant duration of three (3) years, six (6) months due to aortic stenosis and regurgitation caused by pannus growth.The patient presented with heart failure and shortness of breath.The procedure was performed with a non-edwards transcatheter valve.The patient status was reported as recovered.Per the doctor, the leaflets were only movable in the center of the valve due to pannus formation.
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Added information to h6.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.Pannus overgrowth, or host tissue, is considered a form of non-structural valve dysfunction.The growth of host tissue on the sewing ring is expected and is a natural part of the healing reaction to prosthesis implantation.In contrast, if there is an excessive amount of pannus growth, it can extend onto the cusp surfaces leading to thickening of the cusps, leaflet immobility, elevated gradients, and stenosis.Host tissue growth can also contribute to cusp retraction or curling resulting in valvular regurgitation.Host fibrous (pannus) tissue growth is not a malfunction of the device related to a manufacturing deficiency.The most likely cause is patient factors.
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