Date of death - estimated.Date of event - estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant - estimated.The device was not returned for evaluation.A review of the lot history record could not be conducted because the part and lot number was not provided.The reported patient effect of death is listed in the xience v everolimus eluting coronary stent systems instructions for use (ifu) 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other patient events mentioned are filed under a separate medwatch mfr number.
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This is filed to report patient deaths.It was reported through a research article that the xience stent family may be related to death, myocardial infarction, target lesion re-vascularization, stent thrombosis and re-hospitalization.Specific patient information is documented as unknown.Details provided in the attached article titled: "incidence and predictors of target lesion failure in patients undergoing contemporary des implantation¿individual patient data pooled analysis from 6 randomized controlled trials".
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