(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.The reported device expiration issue was able to be confirmed.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 other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as the device was used past the expiration date.It should be noted that the xience xpedition everolimus eluting coronary stent system instructions for use states: for single use only.Do not resterilize or reuse.Note the product use by date.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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