The device was not returned for evaluation as it 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 lesion located in the left anterior descending coronary artery that was mildly calcified, moderately tortuous and 90% stenosed.The lesion was pre dilated with a 2x8 semi-complaint balloon and the 3.5x15mm xpedition stent was implanted.Post implantation of the stent, a proximal edge dissection was noted.Another xience xpedition was implanted to treat the dissection.There was no adverse patient sequela.No additional information was provided.
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