Outcomes to adverse event, date of event, implant date: estimated dates.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The reported patient effect of death is listed in the absorb instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported death, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.The xience stents and the additional adverse patient effects referenced are being filed under separate medwatch report numbers.Article titled: ¿three-year clinical outcomes of the absorb bioresorbable vascular scaffold compared to xience everolimus-eluting stent in routine pci in patients with diabetes mellitus¿aida substudy".
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It was reported through a research article identifying absorb bioresorbable vascular scaffold and xience everolimus-eluting stent that may be related to the following: target-vessel failure, target vessel myocardial infarction, stenosis, thrombosis, target-vessel revascularization, and cardiac deaths.No additional information was provided.Details are listed in the attached article, titled "three-year clinical outcomes of the absorb bioresorbable vascular scaffold compared to xience everolimus-eluting stent in routine pci in patients with diabetes mellitus¿aida substudy".
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