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 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 performed was to treat a mildly tortuous, moderately calcified left anterior descending artery (lad) that is 80% stenosed.The lesion was serially pre-dilated with unspecified 3.0x8mm and 3.0x12mm balloons.A 3.0x38mm xience xpedition was successfully deployed; however, a check shot revealed there was a dissection at the distal end.The dissection was treated with a 2.75x08mm unspecified stent.It was noted results were good with timi iii flow without any residual stenosis.There were no adverse patient sequela, and no clinically significant delay.No additional information was provided.
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