MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-100/I20-40
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
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 through the right access.An angiogram showed a type iiia endoleak.The physician performed balloon touch-up from the proximal side to the distal side of the vela suprarenal but the endoleak did not disappear.The physician then elected to add a 28.5mm gore cuff (non-endologix) on the distal end of the vela suprarenal.The endoleak remained, the physician decided to monitor the patient under follow up and completed the procedure.The patient will be monitored.
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Available patient medical records and imaging studies have been received for evaluation by a 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.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 iiia endoleak complaint is confirmed.This is consistent with the reported adverse event/incident.The type iiia endoleak is likely related to the superior stent margin of the main body being placed in a 37 degree infrarenal angle making this anatomy related.The clinical assessment determined that there was evidence to reasonable suggest a type ii endoleak occurred that was not included in the event as reported.The type ii endoleak was discovered during review of the undated angiogram movies.There was likely a contributory type ii endoleak of the lumbar artery which is also anatomy related.The complaint is most likely anatomy related.Procedure related harms could not be determined.The final patient status was reported as being monitored.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.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: 22186226
• Report Number: 3011063223-2025-00109
• Device Sequence Number: 8401972
• Product Code: MIH
• UDI-Device Identifier: 00818009014405
• UDI-Public: (01)00818009014405(17)280107
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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 Model Number: BEA28-100/I20-40
• Device Lot Number: 2872441001
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2025
• 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 # 2820340014.; GORE CUFF 28.5MM (NON-ENDOLOGIX).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown