The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of perforation is listed in the xience alpine, everolimus eluting coronary stent system (eecss), instructions for use (ifu) as a known patient effect of coronary stenting procedures.It was reported that the device was used in the left internal carotid artery petrous portion.The xience alpine everolimus eluting coronary stent system (eecss), domestic,ifu states: the xience alpine stent system is indicated for improving coronary artery luminal diameter in patients.In addition, the xience alpine stent system is indicated for treating de novo chronic total coronary occlusions.It is unknown if the ifu deviation contributed to the reported event.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the reported treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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It was reported that during a left internal carotid artery stenting procedure, after successful implantation of the xience alpine stent, a perforation was noted.Two covered stents were successfully implanted, sealing the perforation.There was no adverse patient sequela.No additional information was provided.
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