MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-100/I20-40
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
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 indeterminate endoleak was determined to be a type iiib endoleak.The additional endovascular procedure complaint is confirmed.The left iliac sac growth of 5.7mm complaint is confirmed.This is consistent with the reported adverse event/incident.There were two previous revisions of previously placed grafts making this cautionary product use.Device, user, procedure or anatomy relatedness of the complaint could not be determined.The procedure related harm identified was an access site complication (right groin hematoma) that required one unit of blood.The final patient status was discharged on 02 february 2026 in stable condition.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: b6: relevant tests and lab data has been updated g3: date received by manufacturer has been updated.H6: investigation type codes: remove code 4118 h6: result code: remove code 3233 h6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implantation of an afx2 bifurcated stent graft (bsg) and an afx vela suprarenal on (b)(6) 2017.During the initial procedure, the patient¿s right iliac artery was noted to be slightly wide (ectatic); no intervention was performed at the time, and the physicians opted for ongoing monitoring.On (b)(6) 2025 the physician elected to implant an ovation ix and afx limb stent graft.Approximately on (b)(6) 2025 the physician elected to implant a gore ibe (non-endologix) due to slow sac growth from what was thought to be from an ectatic iliac that became aneurysmal.On (b)(6) 2026, during a routine follow up, it was identified that this could be a type iii endoleak.Intervention occurred on (b)(6) 2026 with implant of an afx2 bsg and the leak was resolved.
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Available patient medical records and imaging studies have been received for evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

• 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: 24372854
• Report Number: 3011063223-2026-00016
• Device Sequence Number: 4862987
• Product Code: MIH
• UDI-Device Identifier: 00818009014405
• UDI-Public: (01)00818009014405(17)180601
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 06/01/2018
• Device Model Number: BEA28-100/I20-40
• Device Lot Number: 1699298006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2017
• 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 LIMB STENT GRAFT, LOT # 2842071010; AFX VELA SUPRARENAL, LOT # 1720245007; GORE IBE (NON-ENDOLOGIX); OVATION IX ILIAC LIMB, LOT # FS060724-04
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female