MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-70/I20-30
Medical Device Problem Codes	Off-Label Use (1494); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
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 and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela suprarenal.An angiogram showed an endoleak at the junction of the afx2 bifurcated stent graft and an afx vela suprarenal that the physician determined was either a type iiia or a type iiib endoleak.The physician elected to implant a gore cuff (non-endologix) to overlap the distal half of the afx vela suprarenal.The final angiography showed that the endoleak had disappeared, and the procedure was completed.Approximately two (2) years post initial procedure, the patient presented with a rapidly growing aortic aneurysm diameter and symptoms of anemia.The patient had a reverse taper neck that was significantly bending backward as well as the anemia prior to the initial treatment.The physician has decided that additional treatment is required.
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.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 aneurysm enlargement complaint is unconfirmed and the type iiia endoleak of the aortic components (poor apposition) is confirmed.This is moderately consistent with the reported adverse event/incident.The complaint is likely anatomy related as the superior stent margin of the afx2 main body was placed in the 49.4-degree aortic angulation and thickened calcium caused poor apposition in the angulation, which likely contributed to the type iiia endoleak.The initial procedure was off label due to concomitant product use of a non-endologix cuff.This did not appear to contribute to the reported event.Procedure related harms could not be 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.

• 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: 21095369
• Report Number: 3011063223-2025-00004
• Device Sequence Number: 8629458
• Product Code: MIH
• UDI-Device Identifier: 00818009015105
• UDI-Public: (01)00818009015105(17)250516
• 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
• 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): 12/10/2024

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: 05/16/2025
• Device Model Number: BEA22-70/I20-30
• Device Lot Number: 2577461009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL, LOT # 2594357004; GORE CUFF (NON-ENDOLOGIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male