MAUDE Adverse Event Report: Endologix AFX2; Bifurcated Stent Graft

Model Number	BEA25-90/I20-30
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm on (b)(6)2022 with the implant of an afx2 bifurcated stent graft and an afx vela suprarenal.On (b)(6)2026, an indeterminate endoleak was identified during a medical checkup.Reintervention was performed on (b)(6)2026 to treat bilateral type ib endoleaks.An ovation ix iliac limb was deployed in the left leg while preserving the left internal iliac artery (iia).For the right leg, an attempt was made to preserve the right iia at the time of deployment using a fenestrated afx limb extension; however, cannulation into the right iia was difficult.During the attempt, angiography performed with an altered c-arm angle revealed a clear type ib endoleak from the right leg.Consequently, preservation of the right iia was abandoned, and another afx limb extension was also deployed for relining.Final angiography confirmed the resolution of the type ib endoleak, and the procedure was completed.It was noted, based on imaging findings, that the sit-on/landing of the device might have been insufficient during the initial procedure.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with 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 devices involved remain implanted in the patient; therefore, a device evaluation could not be completed.A clinical evaluation of the adverse event/incident was completed.An examination of the medical imaging received by endologix shows the bilateral type ib endoleaks and the additional endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of the complaint could not be determined.Procedure related harms could not be determined.However, it was reported that the sit-on/landing of the device might have been insufficient during the initial procedure.It is unclear if this contributed to reported event.The final patient status was not reported.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.

• 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 ; +1(800)983-2284
• MDR Report Key: 50046403
• Report Number: 3011063223-2026-00091
• Device Sequence Number: 9617168
• Product Code: MIH
• UDI-Device Identifier: 00818009014825
• UDI-Public: (01)00818009014825(17)241216
• 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: 2022
• 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
• Report Date (Section B): 06/30/2026

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: 12/16/2024
• Device Model Number: BEA25-90/I20-30
• Device Lot Number: 2534944002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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 2553945006)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male