The device was not returned for analysis.Lot history record (lhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other incidents from this lot.The reported patient effect of dissection is listed in the xience xpedition everolimus eluting coronary stent systems instructions for us as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat a lesion in the left anterior descending (lad) artery with 90% stenosis, mild calcification and heavy tortuosity.The 2.75x48mm xience xpedition stent delivery system (sds) was implanted, however, a proximal edge dissection occurred.Another stent was used to treat the dissection.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.No additional information was provided.
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