(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.The incident information was reviewed; however, 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 effects 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 effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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It was reported that an unspecified absorb gt1 scaffold was deployed on an unknown date.Roughly one year post implant, the patient was admitted to the emergency room with scaffold thrombosis.An unspecified xience sierra stent was deployed to successfully treat the thrombosis.Additionally, it was reported that the patient had discontinued their dual antiplatelet drug therapy at 1 year post deployment of the absorb gt1 scaffold.No additional information was provided.
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