Date of event: estimated date of death.Date of event: estimated date of event.The udi is unknown because the part number and lot number were not provided.Date of implant: estimated date of implant.The device was not returned for evaluation.The reported patient effect of death is listed in the xience v and xience nano everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures.A review of the lot history record of the reported lot could not be conducted because the part and lot number were not provided.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 additional adverse patient effects mentioned will be filed under a separate medwatch report number.Article attached: ultrathin bioresorbable polymer sirolimus-eluting stents versus thin durable polymer everolimus-eluting stents.
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It was reported through a research article identifying that xience stents may be related to the following: death, myocardial infarction, ischemia, target lesion failure, thrombosis, revascularization, rehospitalization.This article summarizes clinical outcomes of 450 patients that were treated with xience stents.Specific patient information is documented as unknown.Details are listed in the attached article, titled "ultrathin bioresorbable polymer sirolimus-eluting stents versus thin durable polymer everolimus-eluting stents.".
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