MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-70/I16-30
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Separation Problem (4043)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
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 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 iiia endoleak and crown separation complaints are confirmed.This is consistent with the reported adverse event/incident.Imaging demonstrates proximal stent dilation to 41.5 mm, with the graft fabric line located 26.2 mm below the lowest renal artery and associated crown separation.These findings may be related to aortic remodeling, an unidentified endoleak, and/or device migration over time; however, this could not be conclusively determined.Infrarenal angulation and reduced overlap likely contributed to the type iiia endoleak; however, the exact cause cannot be determined due to the lack of comparative imaging.Device, user, procedure, or anatomy relatedness of complaint could not be determined.Procedure related harms could not be established.It was reported that an intervention utilizing devices from another manufacturer is planned on an unknown date; however, the final patient status was 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/incidents.H3 other text: device remains implanted.
Event or Problem Description
The patient was treated for a fusiform aneurysm with two sacs and a slightly angulated neck with the implant of an afx2 bifurcated stent graft(bsg) and an afx vela suprarenal on (b)(6) 2019.On (b)(6) 2026 the physician reported that uncoupling between the afx2 bsg and the vela suprarenal was confirmed.Furthermore, the bare stent portion of the vela suprarenal was found to be partially detached from the graft, suggesting potential damage.An intervention using devices from another manufacturer is planned for an unknown date.

• 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: 25178663
• Report Number: 3011063223-2026-00054
• Device Sequence Number: 21506127
• Product Code: MIH
• UDI-Device Identifier: 00818009014603
• UDI-Public: (01)00818009014603(17)190613
• 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: 2019
• 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): 04/21/2026

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: 04/13/2020
• Device Model Number: BEA28-70/I16-30
• Device Lot Number: 1948664003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2018
• 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 #2246865001.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male