MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-90/I20-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 was unable to perform an evaluation of the explanted device as it was not returned.A clinical evaluation of the adverse event/incident could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient was reported to be in good condition and was discharged on the thirteenth post-operative day.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 incidents.
Event or Problem Description
The patient was treated for abdominal aortic aneurysm that was protruding to the left on (b)(6) 2019.The afx2 bifurcated stent graft (bsg) was implanted via the left femoral artery.The afx vela suprarenal was implanted per the instructions.The aorta had a slight s-shaped curve from the neck to the aneurysm, and the angiography after touch-up confirmed a type iiia endoleak.The junction of the afx2 bsg and afx vela suprarenal was touched up again, leading to a decrease in the endoleak.Therefore, the procedure was completed.Post-operative follow-ups revealed gradual enlargement of the aneurysm (maximum short-axis diameter: 56mm), but no apparent endoleak was detected.However, due to possible impending rupture, open conversion was performed on (b)(6) 2024.During the open surgery, the aneurysm was opened, and thrombus was removed.Then, blood spurted out from the posterior side of the afx2 bsg.Therefore, the stent graft was explanted, and artificial graft replacement surgery was performed.Upon inspection of the explanted afx2 bsg damage on the bifurcation was identified at the location of the damage corresponding to the site of the blood leakage.The patient was in good condition and was discharged on the thirteenth post-operative day.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• 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: 22133674
• Report Number: 3011063223-2025-00100
• Device Sequence Number: 8408504
• Product Code: MIH
• UDI-Device Identifier: 00818009014825
• UDI-Public: (01)00818009014825(17)200907
• 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: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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: 09/07/2020
• Device Model Number: BEA25-90/I20-30
• Device Lot Number: 1984131002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2018
• 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 SUPRARENAL (LN 2227178003)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male