Dates of death, treatment, and implant: estimated dates.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, thrombosis, occlusion, and perforation 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 xience sierra stent and the additional adverse patient effect of death referenced are being filed under separate medwatch report numbers.Article titled: "xience sierra small sizes report update for 2020.".
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It was reported through a research article identifying implanted small xience sierra stents (2.0, 2.25), documented as small xience sierra, and various other xience drug eluting stents (alpine, xpedition 2.0, xpedition 48, xpedition, prime, and v) identified as "all xience" stents.The small xience sierra stents may have contributed to the following adverse events: death, side-branch closure, myocardial infarction, thrombosis, and target lesion/vessel revascularization.The "all xience" stents may have contributed to the following adverse events: death, side-branch closure, myocardial infarction, thrombosis, perforation, acute coronary artery bypass graft, and target lesion/vessel revascularization.Details are listed in the article, titled ¿xience sierra small sizes report update for 2020.".
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