(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Average age, majority gender, estimated dates, the unique device identifier (udi) is unknown because the part and lot numbers were not provided.There was no reported device malfunction and the product was not returned as it remains implanted.A review of the lot history record could not be conducted because the part and lot numbers were not provided.The reported patient effect of thrombosis as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) is a known adverse event 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.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 bioresorbable vascular scaffold (bvs) that may be related to very late thrombosis.Average patient age and majority gender studied were identified.Details are listed in the attached article, titled, clinical, angiographic, and procedural correlates of very late absorb scaffold thrombosis.
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