It was reported that the procedure was to treat a moderately calcified, moderately tortuous, 90% stenosed lesion in the left circumflex (cx) artery.The vessel was pre-dilatated with a non-abbott balloon and a 3x38mm xience xpedition drug eluting stent (des) was implanted without issue.After implantation, an edge dissection was noted at the proximal end of the implanted stent.Another xience xpedition stent was used to cover the dissection and successfully complete the procedure.There was no adverse patient sequela.No additional information was provided.
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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 (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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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