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 effect of death is listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting 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 additional xience sierra stent and the additional adverse patient effects 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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