MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-100/I16-40
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient images have been received, pending evaluation.Patient medial records have been requested.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.H3 other text : device remains implanted.
Event or Problem Description
The patient was treated for a 68.4 mm in diameter abdominal aortic aneurysm (aaa) with an afx2 bifurcated stent graft and an afx vela suprarenal extension on (b)(6) 2021.It was reported in (b)(6) 2025 the computed tomography (ct) scan revealed that the aaa was 63 mm in diameter.Currently the ct scan revealed that the aaa is 66 mm in diameter.There is an increase in the aortic neck angulation to 75 degrees.There is separation of the afx2 abdominal aortic aneurysm stent and the afx vela suprarenal extension and a type iiia endoleak.The patient is asymptomatic.The patient is currently being monitored while an intervention is being discussed.
Event or Problem Description
The patient was treated for a 68.4 mm in diameter abdominal aortic aneurysm (aaa) with an afx2 bifurcated stent graft and an afx vela suprarenal extension on (b)(6) 2021.It was reported in (b)(6) 2025, the computed tomography (ct) scan revealed that the aaa was 63 mm in diameter.Currently the ct scan revealed that the aaa is 66 mm in diameter.There is an increase in the aortic neck angulation to 75 degrees.There is separation of the afx2 abdominal aortic aneurysm stent and the afx vela suprarenal extension and a type iiia endoleak.The patient is asymptomatic.The patient was being monitored while an intervention was being discussed however, the endologix intervention procedure was cancelled for an unknown reason.
Additional Manufacturer Narrative
An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.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.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 iiia endoleak and aneurysm enlargement to 9.7mm complaints are confirmed.This is consistent with the reported adverse event/incident.The complaint is likely anatomy related.Procedure related harms could not be determined.The clinical evaluation also shows reasonable evidence to reasonably suggest an increase in infrarenal angulation from 52.2degree to 76.3degree is consistent with aortic remodeling and likely contributed to the reported aneurysm enlargement, graft separation, and type iiia endoleak.The final patient status was reported as being monitored while an intervention is being discussed.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: 23928783
• Report Number: 3011063223-2025-00199
• Device Sequence Number: 9295983
• Product Code: MIH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup,Followup
• Report Date (Section B): 12/05/2025

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: 01/04/2024
• Device Model Number: BEA28-100/I16-40
• Device Lot Number: 2414272003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 09/01/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/26/2026; 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• 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 SUPRARENAL LOT# 2404332002.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male