The device was not returned for evaluation.The reported patient effect(s) of dissection is listed in the xience prime, xience prime sv, and xience prime ll everolimus eluting coronary stent system instructions for use as a known patient effect(s) of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect(s), 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 performed to treat a lesion with moderate calcification, moderate tortuosity, and 90% stenosis in the left anterior descending artery.A 3.5 x 28 mm xience prime stent was implanted to the target lesion; however, an edge dissection was noted at the distal end.Another unspecified stent was deployed to treat the dissection.The procedure ended with good result.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
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