MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-70/I20-30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2026
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.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.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 initially implanted with an afx2 bifurcated stent graft, a vela suprarenal, a vela infrarenal, an afx iliac limb, and an ovation ix iliac limb to treat an abdominal aortic aneurysm (aaa) on (b)(6) 2026.Three (3) days post initial procedure, the patient was scheduled for an additional procedure for an unknown reason; however, the procedure was cancelled as the patient changed their mind about having this procedure and was moved to comfort care.No further information is currently available.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.

• 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: 24711860
• Report Number: 3011063223-2026-00034
• Device Sequence Number: 5763469
• Product Code: MIH
• UDI-Device Identifier: 00818009014566
• UDI-Public: (01)00818009014566(17)280715
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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
• Report Date (Section B): 03/05/2026

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 Model Number: BEA28-70/I20-30
• Device Lot Number: 2926542009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2025
• 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 ILIAC LIMB, LOT # 2910181011.; AFX VELA INFRARENAL, LOT # 2919966005.; AFX VELA SUPRARENAL, LOT # 2974285006.; OVATION IX ILIAC LIMB, LOT # FS100825-42.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male