(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.It should be noted that the xience sierra everolimus eluting coronary stent system instructions for use (ifu) states: do not use after the use by date.The expiration date of the product is important for sterility, efficacy, and performance of the device.Potential adverse events of using the device post expiration date include fever and stenosis/restenosis.However, in this case there was no reported device failure or patient adverse event reported.The investigation determined the reported issue appears to be related to user error as the device was used past the expiration date.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
|