MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-120/I20-40
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Abdominal Pain (1685); Clinical Endoleak (4843)
Date of Event	05/04/2026
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 type iiib endoleak of the main body complaint is confirmed.The additional endovascular procedure is confirmed.This is consistent with the reported adverse event/incident.No contributing factors were identified.Device, user, procedure or anatomy relatedness of the complaint could not be determined.Procedure related harms for the complaint could not be determined.The final patient status was reported to be fine with no other symptoms and has discharged home.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 h3 other text : device remains implanted.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela infrarenal on (b)(6) 2022.On (b)(6) 2025 a follow up ct was taken, reviewed, and was deemed clean.On (b)(6) 2026, the patient presented emergently with abdominal pain at an unknown facility.An angiogram subsequently identified a type iiib endoleak at the level of the aortic bifurcation.Patient referred to ao mauriziano torino where reintervention was performed immediately.An afx2 bsg, an afx vela infrarenal, and two endurant iliac limbs (non-endologix) were implanted.The patient is reported as being fine with no other symptoms and has been discharged home.

• 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: 25409955
• Report Number: 3011063223-2026-00061
• Device Sequence Number: 10302339
• Product Code: MIH
• UDI-Device Identifier: 00818009014665
• UDI-Public: (01)00818009014665(17)240827
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: 08/27/2024
• Device Model Number: BEA25-120/I20-40
• Device Lot Number: 2502221002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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 # 2499039008
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male