MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C100-O20 V
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm on (b)(6) 2021 with the implant of an afx2 bifurcated stent graft (bsg) via right access, an afx vela suprarenal just below the renal arteries, and a gore (non-endologix) excluder cuff in the right common iliac artery aligned with the common iliac artery bifurcation to preserve the internal iliac artery.On 27 january 2026 a contrast-enhanced computed tomography confirmed an endoleak, although there was no aneurysm sac enlargement observed.The origin of the endoleak could not be identified and was suspected to be either a type ia or type iii endoleak.Reintervention was completed on (b)(6) 2026.First an angiography was performed from the proximal end of the afx vela suprarenal that confirmed it was a type ia endoleak; however, the angiography from within the afx2 bsg did not show any type iii endoleak.Therefore, the condition was diagnosed as a type ia endoleak.The physician elected to implant a gore (non-endologix) excluder cuff aligned with the proximal end of the afx vela suprarenal.After balloon touch-up, the type ia endoleak was confirmed to have resolved, and the procedure was completed.The final patient status was not provided.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.
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 pre-planning medical imaging received by endologix found the type ia endoleak is confirmed.The additional endovascular procedure is unconfirmed.This is moderately consistent with the reported incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms could not be determined.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The procedure is outside the indications of use (off-label) due to the use of adjunctive devices (gore (non-endologix) excluder cuff) not compatible with afx system per the ifu; however, it is not likely that the concomitant use contributed to the reported event.The final patient status remains unknown as it was not made available to endologix.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.

• 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: 24503253
• Report Number: 3011063223-2026-00021
• Device Sequence Number: 13251862
• Product Code: MIH
• UDI-Device Identifier: 00818009013651
• UDI-Public: (01)00818009013651(17)240601
• 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: 2021
• 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): 02/04/2026

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: 06/01/2024
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 2471522004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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# 2474113003); GORE (NON-ENDOLOGIX) EXCLUDER CUFF (LOT# UNK)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male