The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the aortic dissection and death are unconfirmed.This is not consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The patient was being treated for a right common iliac artery 41.9mm in diameter aneurysm.It is unclear if the off-label nature of this case contributed to the reported event.The final patient status was reported as deceased.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Corrections g3: awareness date has been updated.H6: medical device problem codes: remove code 4065.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.
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