H10: additional manufacturer narrative: 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.
|
It was reported a patient with a 23mm 11500a aortic valve, implanted in the pulmonary position, has been placed under evaluation for a valve-in-valve after an implant duration of two (2) years, seven (7) months due to significant stenosis of the rvot, and mild pulmonary insufficiency.
|