(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported device expiration issue appears to be related to the use error.It should be noted that the xience alpine everolimus eluting coronary stent system (eecss), domestic electronic instructions for use states: note the product use by (expiration) date specified on the product label.It is likely the ifu deviation of device expiration issue contributed to the event.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
|
It was reported that on 08/24/2020, a 3.50x12mm xience alpine stent was successfully implanted in the mid circumflex artery, after the expiration date which was 07/03/2020.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
|