The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.A conclusive cause for the reported difficulties cannot be determined; however, the subsequent treatments appear to be related to the operational context of the procedure.It was reported that a xience sierra stent delivery system (sds) was attempted to be advanced in-between two previously implanted stents.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use states: when treating multiple lesions within the same vessel, stent the distal lesion prior to stenting the proximal lesion.Stenting in this order obviates the need to cross the proximal stent during placement of the distal stent and reduces the chance of damaging or dislodging the proximal stent.It is unknown if the ifu deviation(s) directly caused or contributed to the reported event.There is no indication of a product quality issue with respect to manufacture, design or labeling.(b)(4).
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