MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-80/I16-40
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event remain implanted in the patient; therefore, a device evaluation will not be completed.Pre-planning and computed tomography imaging have been received for further evaluation by a clinical specialist.A follow-up report will be submitted upon completion of the clinical assessment.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm on (b)(6) 2025.Bilateral coil embolization of the internal iliac arteries was performed.A non-endologix gore excluder leg was implanted from the origin of the right common iliac artery (rcia) via a dryseal 12fr sheath.The sheath was replaced with an afx introducer sheath, which was advanced to the proximal portion of the excluder leg.To prevent distal migration of the excluder leg, the afx2 bifurcated stent graft (bif) delivery system was cautiously advanced by seating it on the afx introducer sheath.Subsequently, the afx bif was deployed without issues.After confirming the renal artery bifurcation with angiography, a vela afx vela suprarenal was deployed to align with the left renal artery.The physician opted to perform the angiography without touch-up at this stage.Angiography confirmed blood flow to an aneurysmal segment of the rcia.Suspecting a type iiia endoleak, touch-up of the rcia, including the junction between the excluder leg and the afx2 bif, was performed twice.However, the endoleak persisted.Suspecting a type iiib endoleak, intra-graft angiography was performed while occluding the distal rcia with a balloon.Blood flow into the aneurysm was confirmed, and the endoleak was thus judged to be type iiib.Consequently, a second afx2 bif was deployed for relining.Subsequent angiography showed blood flow at the same site with delay; however, the procedure was concluded with the decision to continue observation.The afx2 system was evaluated using endologix components.The safety and effectiveness of other stent or stent graft devices used in conjunction with the afx2 system have not been established.
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 device was not returned to endologix for evaluation because it remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the type iiib endoleak (unresolved) complaint is unconfirmed.This is not consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.It should be noted that a planned intervention was performed using an excluder (non-endologix) limb was implanted to treat a right common iliac artery aneurysm.The safety and effectiveness of other stent or stent graft devices used in conjunction with the afx2 system have not been established.It is unclear if this concomitant product usage contributed to the reported event.Additionally, contrast was initially seen at the hypogastric artery and was delayed in character.A type iiia or type ii endoleak could not be excluded.A type iiib endoleak could not be conclusively ruled out.The final patient status was reported as being monitored.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation¿s 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 - updated g3: awareness date ¿ updated h6: investigation finding codes - remove code 3233 h6: investigation conclusion codes - remove code 11.

• 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: 23768486
• Report Number: 3011063223-2025-00190
• Device Sequence Number: 15869847
• Product Code: MIH
• UDI-Device Identifier: 00818009014467
• UDI-Public: (01)00818009014467(17)261127
• 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: 2025
• 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
• Report Date (Section B): 12/08/2025

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 Model Number: BEA28-80/I16-40
• Device Lot Number: 2739185003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2023
• 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 (LN 2762264001).; COILS.; GORE (NON-ENDOLOGIX) EXCLUDER LEG.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male