Dates of death, event, and implant: dates estimated.The additional adverse patient effects referenced will be filed under a separate medwatch report #.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The reported patient effect of death is listed in the xience v everolimus eluting coronary stent systems 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.However, the 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.The udi is unknown as the part and lot numbers were not provided.
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It was reported through a research article identifying xience that may be related to the following: patient death, thrombosis, myocardial infarction, revascularization, and rehospitalization.This article summarizes clinical outcomes of 99,039 patients that were treated with xience stents.Specific patient information is documented as unknown.Details are listed in the attached article, titled "target lesion failure with current drug-eluting stents evidence from a comprehensive network meta-analysis.".
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