B2: date of death estimated.B3: date of event estimated.D6: implant date estimated.D4: the udi is unknown as the part/lot number was not provided.The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effect of death is listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use as a known adverse event associated with the use of a coronary scaffold in native coronary arteries.A conclusive cause for the reported patient effect of death, and the relationship to the product, if any, cannot be determined; however, the subsequent 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 effects listed in the article is captured under a separate medwatch report.Literature attachment e-186987 article, titled: "impact of post-implantation time on bioresorbable vascular scaffold outcomes for type c versus non-type c coronary lesions: a longer-term study.".
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It was reported that this article titled, "impact of post-implantation time on bioresorbable vascular scaffold outcomes for type c versus non-type c coronary lesions: a longer-term study" captured outcomes of 457 consecutive patients who had a bioresorbable vascular scaffold implanted between march 2014 and april 2018.The article states, "with a median follow-up of 56.4 (48.6 to 62.6) months, the incidence of cardiac death, target vessel mi [myocardial infarction], tlr [target lesion revascularization], tlf [target lesion failure], and definite/probable scaffold thrombosis for the patients was 0.2%, 1.3%, 7%, 7.4%, and 0.7%, respectively." adverse patient effects included cardiac death, target vessel mi, and clinically driven percutaneous or surgical tlr.Please see the attached article for additional information.
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