The device was not returned for analysis.The lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history did not indicate a lot specific quality 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.The reported patient effect(s) of dissection is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect(s) of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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