(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Udi#: in the absence of a reported part number, the udi cannot be calculated.Date of implant 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 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 thrombosis as listed in the absorb gt1 instructions for use, 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 effect, 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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