Exemption number e2019001.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 was unable to determine a conclusive cause for the reported expiration date error as the device was not returned for analysis.It should be noted that 41 units from this lot were re-worked to extend the shelf life of the device; however, this account did not receive any of the re-worked units.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that when opening the packaging for a 2.25x18mm xience sierra stent delivery system on the sterile table, it was inspected and noted that the device was expired on 10/7/2019.However, the pouch indicated a different date.The device was not used and there was no patient involvement.The chipboard box was discarded.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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