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 intimal dissection is listed in the xience xpedition, everolimus eluting coronary stent system 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.Based on the information reviewed, 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 the procedure was to treat a lesion located in the left circumflex coronary artery.The lesion was pre-dilated with a non-abbott balloon and the xience xpedition stent implanted.After post-dilatation with an nc traveler balloon, a distal edge dissection was observed.Another xience xpedition was implanted, successfully treating the dissection.There was no reported adverse patient sequela.No additional information was provided.
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