(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 instruction for use states: applying excessive force to the delivery system can potentially result in loss or damage to the stent and/or delivery system components.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the previously implanted stent during advancement causing the reported failure to advance.A projecting strut from the previously implanted stent entrapped the device during removal causing the reported stent entrapment.Force was reportedly applied due to the entrapment causing the reported stent dislodgement and subsequent treatment.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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