The patient deaths will be filed under a separate medwatch report #.The device was not returned for evaluation.The reported patient effect(s) of myocardial infarction and thrombosis are listed in the xience v everolimus eluting coronary stent systems instructions for use, as a known patient effect(s) of coronary stenting procedures.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.A conclusive cause for the reported patient effect(s) of myocardial infarction, thrombosis, hemorrhage, neurological deficit 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 udi is unknown because the part and lot #s were not provided.Title: the hypercholesterolemia paradox in percutaneous coronary intervention: an analysis of a multicenter pci registryna.
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It was reported through a research article identifying xience v that may be related to the following: patient death, thrombosis, myocardial infarction, hemorrhage, neurological deficit.This article summarizes clinical outcomes of 1866 patients that were treated with xience v stents.Specific patient information is documented as unknown.Details are listed in the article, titled "the hypercholesterolemia paradox in percutaneous coronary intervention: an analysis of a multicenter pci registry.".
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