MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-90/I16-30
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient previously underwent implantation of an afx2 bifurcated stent graft as a treatment for an abdominal aortic aneurysm (aaa) on (b)(6) 2021.During a regular follow-up, imaging was performed using computed tomography (ct).The review of these images revealed the presence of a type 1a endoleak.Given the findings, the proposed plan is to add an aortic extension.Sufficient aortic neck remains available, which will allow for restoration of proper sealing with the extension.At present, the patient is stable and continues to be monitored.
Additional Manufacturer Narrative
The reported incident was investigated in alignment with endologix operating procedures and work instructions.Endologix requested medical records and medical imaging from the facility; however, no response was received.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 could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient status is reported as stable.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: 25447561
• Report Number: 3011063223-2026-00063
• Device Sequence Number: 21198533
• Product Code: MIH
• UDI-Device Identifier: 00818009014863
• UDI-Public: (01)00818009014863(17)230604
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2023
• Device Model Number: BEA22-90/I16-30
• Device Lot Number: 2359644004
• 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: 05/13/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2020
• 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: Other
• Patient Sex: Male