MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-80/I20-40
Medical Device Problem Codes	Off-Label Use (1494); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2020.The left internal iliac artery (iia) was embolized and a gore excluder (non-endologix) leg was implanted in the left common iliac artery (cia), after which an afx2 bifurcated stent graft, a vela suprarenal and a vela infrarenal were implanted.Approximately five and a half (5.5) years post initial procedure, during a follow-up on an unknown date, it was reported that there was an indeterminate type endoleak and sac enlargement were observed.The physician elected to treat the patient and an additional intervention was performed.After embolizing the right iia, an ovation ix iliac limb was implanted from the right cia to the external iliac artery (eia) via a left approach by crossing over the afx2 bifurcated stent graft with a guidewire.The delivery system was then retrieved without any issues.An ovation ix iliac extension was implanted via a left approach using a 14 fr dryseal (non-endoligix) sheath, overlapping the distal end of the previously placed ovation ix iliac limb by half the graft length.During retrieval of this delivery system, the tip interfered with the afx2 bifurcated stent, causing difficulty with the retraction.The delivery system was eventually retrieved; however, imaging showed damage to the afx2 bifurcated stent.Touch-up was performed on the right leg and on the damaged stent.Final angiogram confirmed no endoleaks, and the procedure was completed.The decision was made to monitor the patient for the damaged afx2 stent.Note: 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 in the investigation results.
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records are not available.Imaging studies have been received for further evaluation by the clinical specialist.A follow-up report will be submitted upon completion of clinical analysis.H3 other text: device remains implanted.
Additional Manufacturer Narrative
The reported 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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 medical records and/or medical imaging received by endologix shows that the indeterminate endoleak, aneurysm enlargement, buckled material (endoskeleton at the afx bifurcation) and additional endovascular procedure are unconfirmed.This is not consistent with the reported adverse event/incident.The aneurysm sac increased by 4.2 mm; however, the time frame over which this change occurred is unclear.Growth of less than 5 mm does not meet the standard threshold for defining aneurysm enlargement.A 14 fr dryseal sheath (non-endologix) was used with an ovation iliac extension across an existing afx2 bifurcated stent, which is off-label per the device ifu.This off-label use may have contributed to interference with the afx2 endoskeleton and reported stent buckling; however, this could not conclusively be determined.There was concomitant product use of an ovation left limb at the index procedure with an afx main body.It is unclear if this contributed to the reported event (off label use).Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.It was reported that the procedure was completed without evidence of endoleak; however, final patient status was not provided.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: awareness date has been updated.H6: investigation type codes: remove code 4118.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: 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 ; 8009832284
• MDR Report Key: 23706892
• Report Number: 3011063223-2025-00181
• Device Sequence Number: 10720240
• Product Code: MIH
• UDI-Device Identifier: 00818009014955
• UDI-Public: (01)00818009014955(17)200919
• 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
• 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): 11/11/2025

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: 09/19/2020
• Device Model Number: BEA22-80/I20-40
• Device Lot Number: 1988437007
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2018
• 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: COILS (NON-ENDOLOGIX).; EXCLUDER (NON-ENDOLOGIX).; VELA INFRARENAL, LOT # 2276975003.; VELA SUPRARENAL, LOT # 2238153010.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male