Estimated date of death.Estimated date of event.Estimated date of implant.The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the lot number was not reported and the product was not returned for analysis.The reported patient effect of angina, aneurysm, occlusion and death are listed in the xience prime everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.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.There is no indication of a product quality issue with respect to manufacture, design or labeling.Literature attachment: article title "case series of coronary artery aneurysmsafter everolimus eluting stent implantation and comparison with sirolimus eluting stents ".
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