MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C100-O20 V
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, follow-up report will be submitted.
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.Routine follow-up performed in (b)(6) 2025 identified a possible type ib endoleak or possible type ii endoleak.Reintervention was completed on (b)(6) 2025.Angiography confirmed a type ia endoleak which was successfully treated with the implant of an ovation ix extender.The final patient status was reported to be doing well.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Endologix made three good faith efforts to retrieve a reported adverse event/incident-related medical imaging.However, the user facility did not respond to requests for this information.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 found the type ia complaint is confirmed.The additional endovascular procedure is confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest there was a type ii endoleak of a lumbar artery that was not in the event as reported.These findings were discovered during an examination of the discharge summary dated (b)(6) 2025.Device, user, procedure or anatomy relatedness of this complaint cannot be determined.Procedure related harms could not be identified.The final patient status was reported as being discharged on post operative day one and hospital day seven.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.Corrections: g3: awareness date ¿ updated.H6: investigation finding codes ¿ remove code 3233.H6: investigation conclusion codes ¿ remove code 11.

• 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
• MDR Report Key: 22094881
• Report Number: 3011063223-2025-00096
• Device Sequence Number: 20559530
• Product Code: MIH
• UDI-Device Identifier: 00818009013651
• UDI-Public: (01)00818009013651(17)230714
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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 Expiration Date: 07/14/2023
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 2368835015
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2021
• 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 STENT GRAFT (LOT# 2469661004).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male