(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of occurrence has been estimated.The udi is unknown because the part and lot numbers were not provided.Date of implant has been estimated.There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record of the reported lot could not be conducted because the part and lot numbers were not provided.The reported patient effects of myocardial infarction, thrombosis and stenosis as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Literature attachment: bioresorbable everolimus-eluting vascular scaffold for patients presenting with non st elevation-acute coronary syndrome: a three-years follow-up.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.[(b)(4)].
|
The following information was reported through a research article titled, "bioresorbable everolimus-eluting vascular scaffold for patients presenting with non st elevation-acute coronary syndrome: a three-years follow-up." it was reported that the study was to investigate three-year outcomes of patients presenting with non st elevation - acute coronary syndrome (nste-acs) treated with bioresorbable everolimus-eluting vascular scaffolds (brs).The primary device-oriented endpoint (target lesion failure, tlf) includes a combination of adverse events: target vessel myocardial infarction or clinically driven target lesion revascularization.Additional endpoints included scaffold restenosis and scaffold thrombosis.
|