It was reported that the procedure was to treat a heavily calcified, moderately tortuous, 80% stenosed, de novo left anterior descending artery (lad) lesion.A 3x15mm xience prime drug eluting stent (des) was implanted without issue; however, after implantation, a distal edge dissection was noted.Another stent was implanted to treat the dissection and successfully complete the procedure.There was no adverse patient sequela.No additional information was provided.
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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 prime 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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