Outcomes to adverse, date of event, implant date: dates estimated.The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the part and lot number 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 procedures.A conclusive cause for the reported death and the relationship to the product, if any, cannot be determined.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 additional adverse patient effects referenced are being filed under a separate medwatch report#.The udi is unknown because the part and lot #s were not provided.
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It was reported through a research article identifying xience v that may be related to the following: death, myocardial infarction, thrombosis, and revascularization.Specific patient information is documented as unknown.Details are listed in the article, titled: three-year clinical outcome of patients with bifurcation treatment with second-generation resolute and xience v stents in the randomized twente trial.
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