The device was not returned for analysis.The 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 similar incidents from this lot.The reported patient effect of dissection is listed in the xience prime, xience prime small vessel (sv), and xience prime long length (ll), everolimus eluting coronary stent systems instructions for use 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 lesion in the left anterior descending (lad) artery with mild calcification and mild tortuosity.The 3.5x28mm xience prime stent delivery system (sds) was advanced to the target lesion and the stent was implanted; however, a distal edge dissection was noted.Therefore, a 3x15mm xience prime stent was used to treat the dissection.There was no adverse patient sequela.No additional information was provided.
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