The patient deaths referenced will be filed under a separate medwatch report #.The additional xience v and rx multilink devices referenced are being filed under separate medwatch report numbers.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effects of thrombosis and myocardial infarction are listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use as known adverse events associated with the use of a coronary scaffold in native coronary arteries.A conclusive cause for the reported thrombosis and myocardial infarction 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 as the part and lot numbers were not provided.Article title: absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in st-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.
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It was reported through a research article identifying absorb, xience v, and multilink that may be related to the following: patient death, myocardial infarction, thrombosis, revascularization, and rehospitalization.This article summarizes clinical outcomes of 870 patients that were treated with absorb scaffolds, xience v, and multilink stents.Specific patient information is documented as unknown.Details are listed in the article, titled "absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in st-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison.".
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