MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-100/I16-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for a fusiform aneurysm with a reversed aortic curvature on (b)(6) 2020 with the implant of an afx2 bifurcated stent graft (bsg).The afx2 bsg was deployed via a left approach.Progressive sac growth was observed on (b)(6) 2026, with aneurysm expansion of 8mm within the last six months.A diagnostic angiography was performed; however, it was not possible to definitively distinguish between a type ia or type iiib endoleak.Reportedly, the physician highly suspected a type iiib endoleak.Reintervention was completed on (b)(6) 2026 in which the physician elected to reline the existing afx2 bsg with a gore (non-endologix) excluder.After confirming no abnormalities, the procedure was completed.The final patient status was not reported.
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 imaging received by endologix found the sac growth and additional endovascular procedure complaints are unconfirmed.The type iiib endoleak of the main body complaint is confirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest there was buckling of the mid main body stent that was not included in the event as reported.These findings were discovered during review of the computed tomography scan (undated).Device, user, procedure or anatomy relatedness of this complaint could not be determined.No procedure related harms were reported.The final patient status remains unknown as it was not made available to endologix.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.H3 other text : device remains implanted.

• 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: 24448112
• Report Number: 3011063223-2026-00020
• Device Sequence Number: 10212614
• Product Code: MIH
• UDI-Device Identifier: 00818009014726
• UDI-Public: (01)00818009014726(17)221108
• 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
• Report Date (Section B): 01/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2022
• Device Model Number: BEA25-100/I16-40
• Device Lot Number: 2307258004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female