MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-120/I16-40
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft (bsg) and an afx vela suprarenal.Approximately seven (7) years post initial procedure, during a routine follow up, the patient presented with both devices getting very close to separating.The physician is unable to determine whether there is a type iii endoleak on the computed tomography scan.Intervention occurred on (b)(6) 2025 with the implant of an alto stent graft system.The patient was reported as doing fine.
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.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.
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 unconfirmed.The additional endovascular procedure complaint is confirmed.This is moderately consistent with the reported adverse event/incident.It was reported that the patient underwent endovascular repair in 2018 and had no documented follow-up until the recent evaluation in 2025 making this cautionary use.A 25 mm suprarenal cuff was used in conjunction with a 25 mm afx bifurcated main body.Per the afx instructions for use (ifu), a proximal extension should be one size larger than the main body to ensure adequate overlap and sealing.Use of a same-sized extension represents cautionary use.It is unclear if this contributed to the reported event.The clinical assessment determined that there was evidence to reasonably suggest aneurysm enlargement of 35 mm occurred that was not included in the event as reported.The aneurysm enlargement was discovered during review of the operative report dated august18,2025.Device, user, procedure or anatomy relatedness of complaint could not be determined.No procedure related harms were identified.The final patient status was reported as discharged home on postoperative day one in stable condition.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: 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 ; 8009832284
• MDR Report Key: 22845794
• Report Number: 3011063223-2025-00139
• Device Sequence Number: 9635191
• Product Code: MIH
• UDI-Device Identifier: 00818009014719
• UDI-Public: (01)00818009014719(17)190403
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 07/24/2025

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 Expiration Date: 04/03/2019
• Device Model Number: BEA25-120/I16-40
• Device Lot Number: 1924342001
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2018
• 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 # 1725055006
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male