MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-100/I20-40
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Rupture (2208); Clinical Endoleak (4843)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela suprarenal aortic extension.Approximately two (2) years post initial procedure, during routine follow up a type 3b endoleak was suspected.The patient is currently being monitored while an intervention is being discussed.
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.
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.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 type 3b endoleak of the bifurcated stent graft is confirmed.This is consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.The clinical assessment determined that there was evidence to reasonably suggest a sac enlargement and possible aaa rupture occurred that was not included in the event as reported.The sac growth and rupture were discovered during review of the 29-month post implant computed tomography (ct) scan.Unable to identify the contributing factors for the type 3b endoleak due to lack of ct study post the initial procedure.The contributing factors for the sac growth (pre ct sac was 47.9mm and event ct sac was 65.6mm) and aaa rupture is likely due to the type 3b endoleak.The patient is currently being monitored while an intervention is being discussed.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: g3: awareness date has been updated, 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: 21910375
• Report Number: 3011063223-2025-00054
• Device Sequence Number: 15631460
• Product Code: MIH
• UDI-Device Identifier: 00818009014672
• UDI-Public: (01)00818009014672(17)250829
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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: 08/29/2025
• Device Model Number: BEA25-100/I20-40
• Device Lot Number: 2606431012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2022
• 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
• 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 SUPRARENAL, LOT # 2561251012.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male