The udi is unknown because the part number and lot number were not provided.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 number were not provided.The reported patient effects of thrombosis, myocardial infarction, cerebrovascular accident and ischemia are listed in the xience v coronary stent systems instructions for use as known patient effects of coronary procedures.A conclusive cause for the reported thrombosis, myocardial infarction, cerebrovascular accident, ischemia, 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.Left main coronary artery disease revascularization according to the syntax score.The additional adverse patient effect of death referenced in under a separate medwatch report number.Na.
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It was reported through a research article that xience stents may be related to death, myocardial infarction, stroke, thrombosis, ischemia, revascularization, surgical intervention, and rehospitalization.This article summarizes clinical outcomes of (b)(6)patients that were treated with xience stents.Specific patient information is documented as unknown.Details are listed in the attached article titled: "left main coronary artery disease revascularization according to the syntax score".
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