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 intimal dissection is listed in the xience xpedition, everolimus eluting coronary stent system (eecss), instructions for use (ifu) 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 subsequent 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 to treat a heavily calcified, 90% stenosed, moderately tortuous lesion in the left anterior descending coronary artery.After implantation of the 3.0x15mm xience xpedition stent, a proximal edge dissection was observed.Another xience xpedition stent was implanted to treat the dissection.There was no adverse patient sequela.No additional information was provided.
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