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 dissection is listed in the xience prime 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 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 de novo lesion located in the left anterior descending coronary artery that was heavily calcified, heavily tortuous and 99% stenosed.The lesion was pre-dilated, then a xience prime stent was implanted and, a distal edge dissection was observed.Another xience prime was implanted as treatment.There was no adverse patient sequela.No additional information was provided.
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