MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	F00786-13
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was being treated for a 71mm diameter abdominal aortic aneurysm (aaa) on (b)(6) 2022 with the implant of an afx2 bifurcated stent graft (bsg), afx vela suprarenal, and afx infrarenal.An epic (non-endologix) vascular stent (10-40) was added to reinforce the left leg, and the procedure was completed after ensuring that there was no endoleak.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx2 system per the ifu.Follow-ups in (b)(6) 2023 initially showed decrease in aneurysm size to 68mm and 59mm respectively; however, follow-ups in (b)(6) 2024 showed increase in aneurysm size to 63mm and 64mm respectively.Reportedly at the (b)(6) 2024 follow-up, there was a sense of discomfort in how the stent graft had been implanted.Open surgery was performed on (b)(6) 2025 to explant all the afx devices, and they were replaced with a "y" (non-endologix) graft.The physician reportedly found holes in multiple locations that have become enlarged over time as well as enlargement of the graft.Final patient status was not provided.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident-related device as well as medical records and medical imaging.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.Endologix performed an evaluation of the returned explanted afx2 bifurcated stent graft, afx vela suprarenal, and afx vela infrarenal.Visual inspection was performed on each device.The afx2 bifurcated stent graft exhibited no observable punctures or tears.In contrast, multiple punctures and/or tears were identified on both the afx vela suprarenal and the afx vela infrarenal components.These findings are consistent with characteristics typically associated with a type iiib endoleak.The presence of these punctures and/or tears in the afx vela suprarenal and infrarenal graft materials supports the reported event of a type iiib endoleak.However, it is important to acknowledge that the observed damage may have also occurred during the explant procedure.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 iiib endoleak and surgical conversion with explant complaint is confirmed.This is consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.The type iiib endoleak is confirmed based on sample evaluation; however, the causation could not be definitively determined, as damage may have also occurred during the explanation procedure.The initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx2 system per the ifu (non endologix stent left limb).It is unclear if this contributed to the reported event.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.Device iteration is afx with duraply.

• 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: 21774329
• Report Number: 3011063223-2025-00039
• Device Sequence Number: 8220478
• Product Code: MIH
• UDI-Device Identifier: 00818009013651
• UDI-Public: (01)00818009013651(17)250330
• 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: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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: 03/30/2025
• Device Model Number: F00786-13
• Device Lot Number: 2562516010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0008-2019Z-0008-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA INFRARENAL (LOT# 2534001010); AFX2 BIFURCATED STENT GRAFT (LOT# 2566358005); EPIC (NON-ENDOLOGIX) STENT (LOT# UNK)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown