MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-90/I16-30
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Aneurysm (1708); Ruptured Aneurysm (4436); Clinical Endoleak (4843)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with sac diameter of 60mm with implant of an afx2 bifurcated stent graft (bsg), an afx vela infrarenal, and an afx vela suprarenal on (b)(6) 2020.The procedure was completed with no confirmed endoleaks.On 11 december 2020, contrast-enhanced computed tomography (ct) confirmed the absence of endoleaks.On (b)(6) 2021, ct confirmed a stable sac diameter of 62 mm.On (b)(6) 2022, ct showed sac enlargement, with the diameter increasing to 69 mm.On (b)(6) 2026, the patient was emergently transported to the hospital due to a rupture of the aaa and artificial vessel replacement was performed.During the open surgery it was reported that there was hardly any overlap between the afx2 bsg and the afx vela infrarenal and the junction was easily separated.On the proximal side, the vela suprarenal was cut, leaving approximately 3cm.A j-graft shield (non-endologix) was used to anastomose the stent graft and the native vessel.On the distal side, the afx2 bsg and the vela infrarenal were explanted.An i-shaped artificial graft (non-endologix) was anastomosed just above the aortic bifurcation and the procedure was completed.
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.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.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 surgical conversion (explant) complaint is unconfirmed.The implant separation with type iiia endoleak, aneurysm enlargement and aneurysm rupture complaints are confirmed.This is moderately consistent with the reported adverse event/incident.The aorta lengthened from approximately 150mm to 187mm, leading to an angulation in the proximal neck (49.3 degrees) and mid aorta (84.3 degrees).This likely contributed to the reported events.The complaint is likely anatomy related.Procedure related harms could not be determined.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 outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.H3 other text: device is unavailable for return.

• 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: 24592304
• Report Number: 3011063223-2026-00026
• Device Sequence Number: 15826464
• Product Code: MIH
• UDI-Device Identifier: 00818009014863
• UDI-Public: (01)00818009014863(17)230406
• 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: 2020
• Device Explanted Year: 2026
• 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): 02/19/2026

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: 04/06/2023
• Device Model Number: BEA25-90/I16-30
• Device Lot Number: 2345650002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2020
• 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#: 2328563006.; AFX VELA SUPRARENAL, LOT#: 2343126003.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male