It was reported that the procedure was to treat a de novo lesion in the mid left anterior descending (mlad) artery.The 2.5x33 xience alpine stent delivery system (sds) was advance to the target lesion and the stent was implanted; however, a distal edge dissection was noted.Therefore, a 2.5x15mm xience alpine stent was implanted to treat the dissection.There was no adverse patient sequela.No additional information was provided.
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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.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.The reported patient effect of dissection is listed in the xience alpine everolimus eluting coronary stent system (ifu), electronic instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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