The device was not returned for evaluation as the device remains implanted in the patient.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 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 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 both heavily calcified, tortuous and 90% stenosed.Post implantation of the xience xpedition stent, a distal edge dissection was observed.Another xience xpedition was implanted as treatment.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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