A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device remains implanted in the patient and not available for analysis; however, procedure images were provided.The review of the provided images found ica occluded just distal to aneurysm.The stent markers appear to be in same position as immediately after implantation.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.The instructions for use (ifu) identifies stent thrombosis as a potential complication associated with use of the device.
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