MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-90/I16-30
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
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.Device iteration is afx2.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft (bsg) and an afx vela suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa) on (b)(6) 2025.There was a slight type ia endoleak observed on angiography, so a proximal touch-up was performed.After the subsequent angiography confirmed the disappearance of the type i endoleak, the procedure was completed.It was reported that the patient's ankle brachial index, (abi) was 1.13/1.16 preoperatively, but a pressure gradient was observed postoperatively and had an abi of 1.12/0.72.The physician elected to implant an express vascular ld 8mm-27mm (non-endologix) stent in the left common iliac artery on (b)(6) 2025 after which the pressure gradient improved.The patient status was not reported.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Per communication with jll (distributor) all information for the evaluation of this event that is available has been provided.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 the type ia endoleak (resolved) is unconfirmed.The main body left limb stenosis and additional endovascular procedure are confirmed.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.The aortic neck length was 13 mm (should be greater than 15mm).It is unlikely that this off label condition contributed to the stenosis of the iliac limb.The final patient status was not reported.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.

• 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: 21901989
• Report Number: 3011063223-2025-00053
• Device Sequence Number: 12960519
• Product Code: MIH
• UDI-Device Identifier: 00818009015136
• UDI-Public: (01)00818009015136(17)270307
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: BEA22-90/I16-30
• Device Lot Number: 2774301005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VELA SUPRARENAL EXTENSION: LOT # 2761444001.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown