MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C100-O20V
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation.Available patient medical records and imaging studies have been received for evaluation by a 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 initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft (bif) and an afx vela suprarenal.The patients¿ neck was tapered.The afx2 bif was implanted via the left access and then the afx vela was implanted.Due to the diameter gap between the proximal and distal neck, the proximal side of the bif did not achieve full apposition to the distal side of the vela.It was reported that there was sufficient overlap (over three stents).No endoleaks were confirmed and the procedure was completed.Approximately one year post initial procedure, the physician elected to perform an aneurysm suture due to aneurysm enlargement (59mm to 63mm) caused by a type ii endoleak form the lumbar artery.The first follow up confirmed the aneurysm had shrunk to 47mm, but during the two year follow up, the aneurysm was shown to have enlarged to 59mm.The physician elected to perform an open surgery.The thrombus and vela were removed and artificial graft replacement surgery was performed.After the thrombus was removed, blood spurted out from the posterior side of the stent graft but the physician could not determine if it was from the bif or the vela.Upon inspection of the removed stent graft, it was revealed that there were three damages on the vela.All of them were right above the junction with the main body.The patient was in good condition and was discharged on the eighth post-operative day.
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 was not available.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the aneurysm enlargement, type iiib endoleak and surgical conversion with explant complaints are unconfirmed.This is not consistent with the reported adverse event/incident.No contributing factors were identified.Device, user, procedure or anatomy relatedness of complaint cannot be determined.No procedure related harms were identified.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 outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Corrections: b6: relevant tests and lab data has been updated g3: date received by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: 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 ; 8009832284
• MDR Report Key: 22203397
• Report Number: 3011063223-2025-00112
• Device Sequence Number: 18053351
• Product Code: MIH
• UDI-Device Identifier: 00818009013651
• UDI-Public: (01)00818009013651(17)220910
• 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: 2020
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 05/29/2025

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: 09/10/2022
• Device Model Number: A34-34/C100-O20V
• Device Lot Number: 2285402007
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• 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 # 2304563004
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male