MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-80/I16-55
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	02/13/2026
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 and the delivery system was discarded.Patient medical records have been received for evaluation by the clinical specialist.A follow-up report will be submitted upon completion of clinical analysis.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, a vela suprarenal aortic extension, an ovation extender and two (2) ovation ix iliac limb stent grafts to treat an abdominal aortic aneurysm (aaa).Note: the afx2 system was evaluated using endologix components.The safety and effectiveness of other stent graft devices used in conjunction with the afx2 system have not been established.Approximately six (6) years post initial procedure, an undetermined type of type 3 endoleak was identified.It was difficult to visualize what is happening due to coils in the left common iliac artery; however, the aneurysm is currently less than 5cm.Upon further evaluation of the patient with a follow up angiogram there was no sign of any endoleak; therefore, no intervention was done.On (b)(6) 2026, the patient presented at the physician¿s office in a non-emergent setting.Upon evaluation, an endoleak was suspected and the patient was scheduled for an angiogram and potential re-lining.Upon completion of the angiogram, it was noted there was a type 3b endoleak.The physician elected to re-line the previously implanted afx2 stent graft with a new afx2 bifurcated stent graft and an afx vela suprarenal.The endoleak was successfully resolved and the patient is doing well.
Additional Manufacturer Narrative
The reported 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 3b endoleak complaint is unconfirmed.The additional endovascular procedure complaint is confirmed.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms could not be determined.The initial procedure was performed off label, as adjunctive devices not compatible with the afx system per the ifu (ovation extender and two (2) ovation ix iliac limb stents) were used.It is unclear whether this contributed to the reported event (concomitant product use).It was reported that the patient was successfully treated, with exclusion of the endoleak, and is currently doing well.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: awareness date has been updated h6: investigation type codes: remove code 4118 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: 24503142
• Report Number: 3011063223-2026-00023
• Device Sequence Number: 13410098
• Product Code: MIH
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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,Followup
• Report Date (Section B): 02/13/2026

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: 06/02/2017
• Device Model Number: BEA25-80/I16-55
• Device Lot Number: 1491491008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 03/06/2026; 04/29/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/03/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2016
• 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 # 1593291013; COILS (NON-ENDOLOGIX); OVATION IX ILIAC EXTENDER, LOT # FS072916-08; OVATION IX ILIAC LIMB, LOT # FS022916-72; OVATION IX ILIAC LIMB, LOT # FS030916-40
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male