MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-120/I20-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and an afx vela suprarenal to treat an abdominal aortic aneurysm (aaa) on (b)(6) 2023.Approximately two (2) years after the initial procedure, it was reported that the patient had an aneurysm enlargement and an endoleak of indeterminate origin, suspected to be either a type 1b or type 3a endoleak.The patient is scheduled to undergo a re-intervention to correct the endoleak.
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.
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 aneurysm enlargement of 34.4mm and additional sac growth of 7.5mm in the right common iliac artery are confirmed.The indeterminate endoleak has been confirmed as a type 1b endoleak of the right common iliac artery and a type 2 endoleak of the internal mesenteric and lumbar arteries.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of the type 1b endoleak could not be determined.The type 2 endoleak is likely anatomy related.Procedure related harms could not be determined.The final patient status was reported as pending additional intervention.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.
Additional Manufacturer Narrative
Corrections: b5: describe event or problem has been updated.H6: health effect - impact code: remove code 4614.H6: medical device problem codes: remove code 4065.G3: awareness date has been updated.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and an afx vela suprarenal to treat an abdominal aortic aneurysm (aaa) on (b)(6) 2023.Approximately two (2) years after the initial procedure, it was reported that the patient had an aneurysm enlargement and an endoleak of indeterminate origin, suspected to be either a type 1b or type 3a endoleak.The patient is scheduled to undergo a re-intervention to correct the endoleak.Now approximately three (3) months post this event, upon imaging the patient with angiogram there was concern that there may be a type 3 endoleak; therefore, the decision was made to do a re-line with a new afx bifurcated stent graft.The patient left the operating room in stable condition.
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 aneurysm enlargement of 34.4mm and additional sac growth of 7.5mm in the right common iliac artery are confirmed.The indeterminate endoleak has been confirmed as a type 1b endoleak of the right common iliac artery and a type 2 endoleak of the internal mesenteric and lumbar arteries.The additional endovascular procedure dated (b)(6) 2025 is confirmed based on records received documenting the reintervention.This is consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of the type 1b endoleak could not be determined.The type 2 endoleak is likely anatomy related.Procedure related harms could not be determined.The final patient status was reported as pending additional intervention.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.H10/h11: additional manufacturer narrative/corrected data has been updated.

• 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: 22394654
• Report Number: 3011063223-2025-00116
• Device Sequence Number: 9060619
• Product Code: MIH
• UDI-Device Identifier: 00818009014399
• UDI-Public: (01)00818009014399(17)240902
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/09/2025

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: 09/02/2024
• Device Model Number: BEA28-120/I20-40
• Device Lot Number: 2503703-007
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 08/19/2025; 09/24/2025; 11/20/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/20/2025; 10/15/2025; 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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# 2572239016
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male