Edwards received information that during avr surgery a 21mm 11500a aortic valve was explanted due to native mitral regurgitation.The same 21mm 11500a was re-implanted after annular enlargement and mvr (non-edwards valve) procedures.Detail of the procedure: during avr surgery severe mitral regurgitation was detected.Causal relationship between the mr and the avr was initially suspected.The implanted 21mm 11500 aortic valve was explanted while the patient was on bypass.However, mr did not decrease.The surgeon then judged that there was no relationship between the mr and the device/avr procedure as the mr was not corrected or decreased by removing the inspiris valve.Annular enlargement was performed and then the same 21mm 11500 aortic valve was re-implanted.(same valve was re-used due to no other prepared product, and there was no problem seen in appearance of the device).Concomitant mvr with non-edwards device was performed.Final echo showed the re-implanted 11500a was functioning well without regurgitation or pvl and no mitral regurgitation post mvr.However, the heart function did not restore and percutaneous cardiopulmonary support (pcps) was initiated, and the patient was moved to the icu.On pod #3, the patient expired and cause of death was due to heart failure.The surgeon commented that there is no causal relationship between the patient death and the device and the procedure.The reason for mr was unknown.There was no notable mr or no particular problems with the native mitral valve prior to avr surgery.Annular enlargement was performed because the 21mm 11500a was thought to be slightly bigger for the patient at the original implant, therefore it was performed before implant for the second time.
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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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