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, 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 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 of the device.
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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 15 mm xience prime stent was deployed; however, a distal edge dissection occurred.Another unspecified stent was used to treat the dissection.There were no adverse patient sequela and no reported clinically significant delay in the procedure.No additional information was provided.
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