MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C75-O20V
Medical Device Problem Codes	Off-Label Use (1494); Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	12/13/2025
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 have been requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was implanted with an afx2 bifurcated stent graft system, an afx vela suprarenal extension, and afx vela infrarenal extension for the treatment of an abdominal aortic aneurysm (aaa) on (b)(6) 2025.It was reported on (b)(6) 2025 the patient presented emergently, an angiogram revealed a type ia endoleak.The physician implanted an afx vela suprarenal aortic cuff extension extending proximally closer to the renal arteries, and a seal was achieved.The type ia endoleak was resolved.The patient status was reported as stable.
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.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 the type 1a endoleak and additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The complaint is likely user and anatomy related.No procedure related harms were identified.The clinical evaluation also shows reasonable evidence to suggest there is progressive aortic degeneration from a preexisting infection (mycotic aneurysm) likely contributed to the type ia endoleak which is anatomy related.At the index procedure, the patient was being treated for a ruptured mycotic aneurysm with a colonic fistula.Use of the afx device to treat a mycotic aneurysm is considered off label, as the device is not designed or cleared for infected aortic tissue and is contraindicated in patients with a condition that threatens to infect the graft.The patient experienced blood loss with a hemoglobin of 5, requiring postoperative packed red blood cell transfusion.The blood loss anemia was likely preexisting secondary to a gastrointestinal bleed and was unrelated to the endovascular procedure.The surgical colectomy was performed for a preexisting abscess/infection and colonic fistula and was not device related.The final patient status was reported as discharged to skilled nursing facility in stable condition on postoperative day 11.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.
Additional Manufacturer Narrative
Patient medical records were received for further evaluation by the clinical specialist.Imaging studies have been requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

• 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: 23991929
• Report Number: 3011063223-2026-00002
• Device Sequence Number: 21458437
• Product Code: MIH
• UDI-Device Identifier: 00818009013583
• UDI-Public: (01)00818009013583(17)271014
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 12/13/2025

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: A28-28/C75-O20V
• Device Lot Number: 2854821001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 02/12/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/02/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2024
• 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 #2863277004.; AFX2 BIFURCATED STENT GRAFT: LOT #2838527R015.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female