It was reported that the procedure was to treat the proximal left anterior descending (lad) coronary artery with moderate calcification, heavy tortuosity, and 80-85% stenosis.The 3.0x18 mm xience prime stent was implanted and there was complete slow flow.The slow flow was managed with thrombosuction.There was no adverse patient sequela.There was no reported clinically significant delay in the procedure.No additional information was provided.
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.The reported patient effect of ischemia is listed in the xience prime everolimus eluting coronary stent systems 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 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.
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