H10: additional manufacturer narrative: 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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It was reported and learned through medical records that a 23mm 11500a aortic valve in aortic position was explanted after an implant duration of two (2) years, seven (7) months and 8 days due to leaflet perforation, degeneration, moderate as and moderate ai, high gradient.The patient presented with sob in acute on chronic chf.The explanted valve was replaced with a mechanical valve.The patient was discharged on pod #5 in stable condition.Per medical records : preoperative ef 30 % and mean gradient 17mmhg with moderate aortic insufficiency.In or findings the valve leaflets appeared relatively normal with the exception of a leaflet perforation in the distal third of the right coronary cusp.There was normal pannus which was sent for micro.Post mechanical valve implant mean gradient 7mmhg and no ai.Pathology of explanted valve leaflets reveal granular appearance and one leaflet fenestration measuring 0.25cm.
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