Date of event, diagnosis, and implant: date is estimated.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The reported patient effects of myocardial infarction, ischemia, and thrombosis are listed in the xience v everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.However, 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 patient effect of death referenced is being filed under a separate medwatch report #.
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It was reported through a research article identifying xience drug-eluting stents that may be related to the following: death, myocardial infarction, ischemia, thrombosis, target vessel revascularization and coronary artery bypass grafting.Details are listed in the article, titled ¿randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the nordic-baltic bifurcation study iv.".
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