The device was not returned for analysis.The reported patient effect of dissection is listed in the xience alpine everolimus eluting coronary stent system (eifu), electronic instructions for use (eifu), as a known patient effect of coronary stenting procedures.The electronic lot history record (elhr) / device history record (dhr) and exception review were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.A conclusive cause for the reported patient effect(s), 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; therefore, no product-related corrective action will be implemented in this case.
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