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, ischemia and dissection, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use is known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the information reviewed, a conclusive cause for the reported patient effects could not be determined.The treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.The xience stent device referenced is being filed under a separate medwatch report number.Attachment: article title,"bioresorbable vascular scaffolds versus drug-eluting stents for diffuse long coronary narrowings"na.
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It was reported in a research article that absorb scaffolds may be related to myocardial infarction, thrombosis, ischemia driven target-lesion revascularization, dissection with intervention and hospitalization.In the same article, xience stents are reported to be related to death, myocardial infarction, thrombosis, ischemia driven target-lesion revascularization and hospitalization.Details can be found in the attached article "bioresorbable vascular scaffolds versus drug-eluting stents for diffuse long coronary narrowings".
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