The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the reported information, it is likely that the guide wire interacted with the implanted 3.50x38 xience skypoint during removal causing the reported difficulty to remove and subsequent material deformation.A conclusive cause for the reported patient effects, 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.The reported patient effects of thrombosis and myocardial infarction are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures there is no indication of a product quality issue with respect to manufacture, design or labeling.
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