The device was not returned for analysis.A review of the corrective and preventive actions (capa) database was performed and revealed no related complaint assessment nonconformities.The lot history record (lhr) revealed no associated manufacturing nonconformities issued to the reported lot.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.The reported patient effect of dissection is listed in the xience alpine everolimus eluting coronary stent system instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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