(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event has been estimated.Date of implant has been estimated.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.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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(b)(4).Udi#: in the absence of reported part number, udi cannot be calculated.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 and complaint history of the reported device could not be conducted because the part and lot numbers were not provided.The reported patient effect of perforation, 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.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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