MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-100/I20-40
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with a left common iliac artery aneurysm (lciaa) on (b)(6) 2019 by implanting a gore (non-endologix) excluder leg first to treat the lciaa, and then an afx2 bifurcated stent graft (bsg) was deployed over the proximal neck and an afx vela suprarenal was deployed just below the renal artery.After a complete touch-up, final angiography confirmed no endoleaks and the procedure was completed.During a six-month follow-up, the aneurysm sac size had shrunk.However, a tendency for gradual aneurysm enlargement was noted starting approximately four years prior (in 2021).In (b)(6) 2025, a computed tomography scan was performed as the aneurysm diameter had increased to approximately 60mm.The results confirmed an apparent endoleak originating from the suture line of the afx2 bsg leg.Reportedly, the lciaa was assessed and found to be in good condition under observation.The endoleak was determined to be a type iiib endoleak originating from the graft of the afx2 bsg leg.Reintervention was completed on (b)(6) 2025 where the physician placed a gore (non-endologix) excluder and a proximal gore (non-endologix) cuff.The secondary procedure was completed without any endoleaks.The final patient status was reported to be discharged home post-secondary procedure.The afx2 system was evaluated using endologix components.The safety and effectiveness of other stent or stent graft devices used in conjunction with the afx2 system have not been established.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Endologix made an attempt to retrieve the reported adverse event/incident-related medical records/medical imaging; however, the distributor reported that the patient medical records and imaging are not available; therefore, a clinical assessment cannot be performed.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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.An evaluation of the device could not be completed because the device was not returned to endologix for evaluation.The devices involved in this event will not be returned for evaluation because it remains implanted in the patient.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 distributor 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 incident could not be evaluated.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.The final patient status was reported to be discharged home post-secondary procedure.No additional investigation of this reported incident is planned.This and similar incident will continue to be monitored.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: 23697041
• Report Number: 3011063223-2025-00182
• Device Sequence Number: 15721356
• Product Code: MIH
• UDI-Device Identifier: 00818009014672
• UDI-Public: (01)00818009014672(17)201102
• 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: 2019
• 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): 11/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2020
• Device Model Number: BEA25-100/I20-40
• Device Lot Number: 2007068005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2018
• 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# 2156839001); GORE (NON-ENDOLOGIX) EXCLUDER LEG (LOT# UNK)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male