MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-100/I20-40
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient; therefore, a device evaluation will not be performed.The distributor reported that the patient medical records are not available.Computed tomography imaging studies have been received for further evaluation by a clinical specialist.A follow-up report will be submitted upon completion of clinical analysis.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2021 with the implant of an afx2 bifurcated stent graft (bsg), an afx vela suprarenal graft, and an afx infrarenal graft.During the initial procedure coil embolization of the inferior mesenteric artery (ima) was performed before the afx2 bsg was deployed.Subsequently, an afx vela suprarenal was deployed just below the renal artery and an afx vela infrarenal was deployed distally for relining due to short overlap length.Complete balloon touch up was performed and the procedure was concluded without any endoleaks.The patient was hospitalized emergently on (b)(6) 2025 due to impending rupture following an outpatient visit where the angiography revealed a suspected type iiia endoleak.Reintervention was completed on (b)(6) 2025 after the physician conducted another angiography that confirmed the type iiia endoleak.The physician elected to implant two (2) gore (non-endologix) excluder cuffs and one (1) endurant (non-endologix) cuff.The secondary procedure was completed and the type iiia endoleak was resolved.The final patient status was not reported.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.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 imaging received by endologix found the additional endovascular procedure complaint is unconfirmed.The type iiia endoleak is confirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest an aneurysm enlargement of 8.1mm occurred that was not included in the event as reported.These findings were discovered during examination of the medical records dated 08 december 2025.The most likely causation for the complaint is anatomy related.The superior stent margins of the main body and infrarenal cuff were positioned within an angled segment of the infrarenal aorta.This likely resulted in poor apposition and contributed to the reported type iiia endoleak.It was reported that there was concomitant use of non-endologix products used to treat the type iiia endoleak.This did not contribute to the reported event.Procedure related harms could not be determined.The final patient status remains unknown as it was not made available to endologix.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: 23945420
• Report Number: 3011063223-2026-00001
• Device Sequence Number: 7830274
• Product Code: MIH
• UDI-Device Identifier: 00818009014672
• UDI-Public: (01)00818009014672(17)240907
• 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: 2021
• 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,Followup
• Report Date (Section B): 12/11/2025

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: 09/07/2024
• Device Model Number: BEA25-100/I20-40
• Device Lot Number: 2504142010
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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# 2469644001).; AFX VELA SUPRARENAL (LOT# 2474227003).; UNKNOWN (NON-ENDOLOGIX) COILING.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male