MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-100/I20-40
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received.Device evaluation is pending.Available patient medical records and imaging studies have been received.Clinical specialist evaluation pending.A follow-up report will be submitted upon completion of returned device evaluation and clinical specialist analysis.Device iteration is afx2.
Event or Problem Description
The patient was treated for a fusiform aneurysm with a long treatment length and severe neck flexion with implantation of an endurant cuff to match the lower renal artery, an endurant iliac extension placed near the flexion apex, an afx2 bifurcated stent graft, and an afx vela infrarenal placed near the flexion apex.The procedure was completed after confirming no endoleak in the final angiogram.Approximately two (2) years post initial procedure open surgery was performed for aneurysm enlargement due to a type v endoleak.During the open surgery a leak due to a suture hole was confirmed near the terminal aorta of the afx2 bifurcated stent graft.The type iiib endoleak was determined to be the cause of the aneurysm enlargement.The physician elected to explant the endurant iliac extension, afx2 bifurcated stent graft, and the afx vela infrarenal.An abdominal artificial vessel replacement surgery was performed to complete the procedure.The final patient status is unknown.It should be noted that this procedure is off label as per the indications for use the afx2 endovascular aaa system (afx2 system) is a family of abdominal aneurysm endografts and delivery systems intended for the endovascular repair of abdominal aortic or aorto-iliac aneurysms.Additionally, 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 returned device was completed.A visual and where possible functional analysis was performed.Endologix received one (1) afx2 bifurcated stent graft and one (1) afx vela infrarenal for evaluation.A comprehensive assessment was conducted on the returned devices, which were securely packaged in a box and transported in a biohazard containment bag.Prior to evaluation, the devices underwent a decontamination process to eliminate potential contaminants.Upon visual inspection of the afx2 bifurcated stent graft, a significant build-up of calcification was noted within the device.A puncture/tear was identified near the terminal aorta, consistent with characteristics indicative of a type iiib endoleak.The reported damage (type iiib endoleak) was confirmed based on the identification of a puncture/tear within the graft material.A tear was also observed on the afx vela infrarenal near the edge of the stent.It is important to note that the identified damages may have 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 that the aneurysm enlargement complaint is unconfirmed.The type iiib endoleak of the distal main body and explant of the main body complaints are confirmed.This is moderately consistent with the reported adverse event/incident.The type iiib endoleak was present on the 4 day post index and 4 month post ct scans.It is unclear if the type iiib endoleak was procedural.The initial procedure is outside the indications of use making this off-label due to concomitant product usage (endurant cuff and endurant iliac extension).It is unclear if this contributed to the reported event.The neck length was 8 mm (should be =15mm), also making this procedure off label.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.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.H3: device evaluated by mfg? - updated.H3: device ret to mfg for eval? - updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• 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: 21854144
• Report Number: 3011063223-2025-00043
• Device Sequence Number: 8817720
• Product Code: MIH
• UDI-Device Identifier: 00818009014405
• UDI-Public: (01)00818009014405(17)250819
• 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: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: 08/19/2025
• Device Model Number: BEA28-100/I20-40
• Device Lot Number: 2604757013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• 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-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA INFRARENAL, LOT # 2582289002; ENDURANT CUFF (NON-ENDOLOGIX); ENDURANT ILIAC EXTENTION (NON-ENDOLOGIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown