MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-100/I16-40
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, follow-up report will be submitted.Device iteration is afx2.
Event or Problem Description
The patient was being treated for endovascular repair (evar) on (b)(6) 2025 with the implant of an afx2 bifurcated stent graft (bsg).An afx sheath was inserted through the right femoral approach.The afx sheath tip marker was positioned slightly proximal to the aortic bifurcation.The contralateral wire of the afx2 bsg was inserted into an afx sheath.An attempt was made to snare the contralateral wire near the aortic bifurcation by using a snare catheter, but it was unsuccessful.The position of the snare catheter was adjusted, and another attempt was made, but it was still unsuccessful.After the snare catheter was advanced to the upper section of the aneurysm, the wire was able to be snared.After ensuring that the tip of the afx2 bsg was located proximally to the aortic bifurcation, the direction of the contralateral wire was checked.The contralateral wire was entangled with the delivery system; therefore, the entire device was rotated to remove the entanglement.The inner core was advanced, and the afx2 bsg was released from the sheath.The wire was still entangled; therefore, the inner core was rotated while the sheath was fixed in an attempt to remove the entanglement.However, the entanglement could not be removed, and an endo knot occurred.Since the afx2 bsg had been deployed and could not be retracted into the sheath, another snare catheter was inserted through a brachial artery to attempt to resolve the issue.After several hours (approximately 7-8), the issue was still not resolved, and the procedure was converted to open surgery.After device retrieval, an artificial blood vessel replacement was performed, and the operation was completed (approximately 10-11 hours).The patient's condition is stable, but there is remaining perfusion disorder (ischemia) of the left leg due to the bi-lateral cut-downs and prolonged surgery.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident-related device as well as medical records and medical imaging.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 was not returned from the user facility.A clinical evaluation of the adverse event/incident was completed.The intraoperative difficult to advance contralateral wire, kinked component (endo knot in contralateral wire), prolonged procedure, additional endovascular procedure (brachial access) surgical conversion, limb ischemia and device explant complaints are unconfirmed.This is not consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.The final patient status was reported as stable however a reperfusion disorder of the left leg persists.No additional investigation of this reported adverse event 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.Corrections: b7: other relevant history - updated g3: awareness date - updated h6: investigation finding codes - remove code 3233 h6: investigation conclusion codes - 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: 21773853
• Report Number: 3011063223-2025-00037
• Device Sequence Number: 15503848
• Product Code: MIH
• UDI-Device Identifier: 00818009014726
• UDI-Public: (01)00818009014726(17)270529
• 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
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: BEA25-100/I16-40
• Device Lot Number: 2811868005
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2024
• 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 Age: 76 YR
• Patient Sex: Male