MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-90/I16-30
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm on (b)(6) 2023.After bilateral internal iliac artery embolization, an afx2 bifurcated stent graft and an afx vela infrarenal were deployed via the right access.The procedure was complete after confirming the absence of endoleaks on the final angiography.Immediately post-procedure, the patient developed acute renal failure that was complicated by systematic thrombosis.Paraparesis was noted.Due to the patient refusing dialysis, no additional treatment was performed.The patient passed away the following day.Reportedly, due to the patient's significant shaggy aorta, it is suspected that thrombi were dislodged into the renal arteries during device maneuvers which led to renal failure.Given the presence of a shaggy aorta from the descending to the abdominal aorta, this event could have occurred with any device due to the underlying vascular condition.While this case should originally have been treated with surgical graft replacement, a stent graft was selected because the patient requested endovascular aneurysm repair.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 renal failure, neurological impairment (paraparesis) and death complaints are unconfirmed.This is not consistent with the reported adverse event/incident.Immediately following the procedure, the patient reportedly developed acute renal failure complicated by systemic thrombosis and paraparesis; the patient refused dialysis, received no further treatment, and was reported deceased the following day (on (b)(6) 2023).These events could not be conclusively confirmed due to the absence of supporting medical records.A shaggy aorta (irregular aortic wall and thrombus lined) was noted, which could have contributed to the systemic thrombosis and subsequent renal failure, paraparesis, and death.Device, user, procedure or anatomy relatedness of complaint cannot be determined.No procedure related harms could be determined.The final patient status was reported as deceased on postoperative day one.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.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 24789901
• Report Number: 3011063223-2026-00039
• Device Sequence Number: 9844781
• Product Code: MIH
• UDI-Device Identifier: 00818009014597
• UDI-Public: (01)00818009014597(17)250914
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2025
• Device Model Number: BEA28-90/I16-30
• Device Lot Number: 2611094010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA INFRARENAL, LOT#: 2591508003.; COILS (NON-ENDOLOGIX).
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male