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 de novo lesion located in the left circumflex coronary artery that was heavily calcified, moderately tortuous and 80% stenosed.The xience xpedition stent was advanced to the lesion and implanted.Post implantation, a proximal end dissection was observed.Another xience stent was implanted to treat the dissection.There was no adverse patient sequela.No additional information was provided.
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