MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C95-O20V
Medical Device Problem Codes	Off-Label Use (1494); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
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.An evaluation of the device was unable to be performed by endologix as it remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.The examination of medical records and/or medical imaging received by endologix shows the implant separation of the proximal extension and bifurcated main body stents is confirmed.The additional endovascular procedure complaint is confirmed.This is consistent with the reported adverse event/incident.The implant separation of the proximal extension and bifurcated main body is most likely anatomy related due to the aortic remodeling as there was an increase in aortic length from 128mm to 164mm with an associated increase in the aortic angulation, likely contributing to the loss of overlap of the proximal extension and main body bifurcated stent.There was concomitant product use of a non-endologix stents in the proximal neck and left common iliac arteries.It is unclear if this contributed to the 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.H3 other text: device remains implanted.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm with a maximum minor axis diameter of 51.5mm with the left common iliac artery (cia) with a dilated portion with a maximum diameter of 25mm on (b)(6) 2019.The left internal iliac artery (iia) embolized with a plug via a right femoral approach, a gore (non-endologix) excluder leg was deployed from the left cia to the external iliac artery (eia) via a left approach.The afx2 bifurcated stent graft (bsg) and the afx vela suprarenal were deployed according to the standard procedure.Intraoperative angiography (dsa) confirmed a type ia endoleak at the proximal side of the afx vela suprarenal; therefore, a gore (non-endologix) excluder cuff (28.5-33) was deployed as an internal lining.The procedure was completed after confirming the resolution of the endoleak.On (b)(6) 2026, junction separation between the afx2 main body and the vela was confirmed during a routine follow-up.Reintervention was performed on (b)(6) 2026.There was no significant leak observed at the junction between the afx2 bsg and afx vela suprarenal.A afx vela infrarenal was deployed at the junction, and the procedure was completed.Note: 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.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• 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: 24573292
• Report Number: 3011063223-2026-00024
• Device Sequence Number: 18739721
• Product Code: MIH
• UDI-Device Identifier: 00818009013637
• UDI-Public: (01)00818009013637(17)210518
• 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): 02/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2021
• Device Model Number: A28-28/C95-O20V
• Device Lot Number: 1934564006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2018
• 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: AFX2 BIFURCATED SENT GRAFT (LN 1958141010); GORE EXCLUDER CUFF (LN UNK); GORE EXCLUDER LEG (LN UNK); PLUG (NON-ENDOLOGIX) (LN UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male