MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-90/I20-30
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Abdominal Pain (1685); Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2019 with the implant of an afx2 bifurcated stent graft, two (2) afx vela suprarenal stent grafts and an ovation ix extender.Reportedly the patient underwent a procedure with interventional radiology in (b)(6) 2025 where a direct sac puncture into the sac with a chive needle (non-endologix) and 6 french sheath (non-endologix) through the vena cava to possibly coil embolize collateral vessels.It was later seen on images that the graft was entered during this procedure and there was a puncture into the graft that was not reported.The patient became symptomatic with belly pain and increasing aneurysm size one month later.Apparently, the hole in the graft remained open and this is likely the reason for a possible type iiib endoleak.The physician elected to reline the graft even though they were unable to identify a definitive endoleak on the initial intraoperative angiogram nor the computed tomography angiogram.Reintervention was completed on (b)(6) 2025 with the implant of an afx2 bifurcated stent graft, an afx vela suprarenal and an ovation ix extender.The patient¿s belly pain was completely resolved and was discharged home post-secondary procedure.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 devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies have been requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Endologix made at least three good faith efforts to retrieve a reported adverse event/incident-related medical records and medical imaging; however, no response was received.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 could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging device, use, procedure, and/or anatomy relatedness to this incident could not be evaluated.The final patient status was reported to be that the patient¿s belly pain was completely resolved and was discharged home post-secondary procedure, however; endologix was unable to confirm this as medical records nor imaging were not provided.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.

• 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: 24116606
• Report Number: 3011063223-2026-00006
• Device Sequence Number: 9689864
• Product Code: MIH
• UDI-Device Identifier: 00818009014825
• UDI-Public: (01)00818009014825(17)200829
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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
• Report Date (Section B): 12/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2020
• Device Model Number: BEA25-90/I20-30
• Device Lot Number: 2283478010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• 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# 1936772003).; AFX VELA SUPRARENAL (LOT# 2270417018).; OVATON IX EXTENDER (LOT# FS030518-38).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male