Since the device was not explanted and the serial number is unknown, no device investigation is possible at this time.Based on the limited information available, it is not possible to draw a definitive conclusion on the reported event.It should be noted that structural valve deterioration is listed as a possible adverse event in the perceval ifu.The event is, therefore, a known inherent risk of the device.The manufacturer has requested additional information on this event, but no further information has been received to date.Should additional information be provided, the manufacturer will provide an update to this reporting activity.
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