MAUDE Adverse Event Report: ENDOLOGIX AFX2; DELIVERY SYSTEM BIFURCATED STENT GRAFT

Model Number	BEA22-90/I16-30
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in this event is pending return.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.H3 other text : device has not been returned.
Event or Problem Description
The patient was being implanted with an afx2 bifurcated stent graft a patient with occlusive disease on (b)(6) 2026.It was reported that after snaring the yellow wire, the physician fellow was pulling the snare and wire out and they got caught in a stenotic area and caused the sheaths to pinch together.When continuing to pull the snared wire, the wire began to unravel.The physician was able to externalize the distal end of the wire, however, the wire continued to unravel, therefore the physician decided to cut the end of the wire and pull the entire graft out.No injury was reported.
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, these were denied.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.Endologix received one (1) afx2 bifurcated stent graft delivery system (bsgds) for evaluation.The devices were shipped in a large shipping box, and a red biohazard bag.Upon receipt of the device there was blood and tissue residue throughout the device.The device was decontaminated.A visual evaluation was conducted.The afx2 bsgds was returned with the contralateral limb cover.The contralateral limb appears compressed and deformed, most likely resulting in the inability to pull the wire through the contralateral vessel (as reported stenotic vessel), resulting in the unraveling of the coil.The exact root cause could not be definitively determined from the evaluation of the returned device, however with the information provided it was most likely related to the patient¿s anatomy of the occlusive disease.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.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: d9: device available for eval has been updated.D9: date received has been updated.H3: device evaluated by mfg has been updated.H3: device ret to mfg for eval has been updated.G3: awareness date has been updated.H6: investigation type codes: remove code 4118.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.

• Brand Name: AFX2
• Common Device Name: DELIVERY SYSTEM 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: 24295971
• Report Number: 3011063223-2026-00011
• Device Sequence Number: 9397791
• Product Code: MIH
• UDI-Device Identifier: 00818009015136
• UDI-Public: (01)00818009015136(17)281017
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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
• Report Date (Section B): 01/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BEA22-90/I16-30
• Device Lot Number: 2955817009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female