MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; ILIAC LIMB

Model Number	TV-IL1410100-J
Medical Device Problem Codes	Complete Blockage (1094); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for a small abdominal aortic aneurysm (aaa) and thrombotic aorta on (b)(6) 2026 with the implant of an afx2 bifurcated stent graft (bsg), an afx vela suprarenal stent graft and an ovation ix iliac limb stent graft.The patient presented emergently on (b)(6) 2026 with a cold left leg due to left iliac limb occlusion where the afx2 bsg leg and the ovation ix limb stent graft overlapped.It was reported that the physician observed an acute bend.Reintervention was completed on (b)(6) 2026.The physician elected to perform a penumbra (non-endologix) thrombectomy and then re-lined the area with a gore (non-endologix) viabahn vbx balloon expandable endoprosthesis.Normal stent graft patency was restored to the limb and patient was doing well.The final patient status was reported to be stable post-secondary procedure.Note: 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 devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies have been requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• Manufacturer (Section G): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; ,; santa rosa CA 95403
• Manufacturer Contact: gary kirchgater ; 3910 brickway blvd; ,; santa rosa, CA 95403 ; 8009832284
• MDR Report Key: 25049061
• Report Number: 3008011247-2026-00036
• Device Sequence Number: 10458065
• Product Code: MIH
• UDI-Device Identifier: 00850007370121
• UDI-Public: (01)00850007370121(17)270614(10)FS061124-39
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• 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): 04/03/2026

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 Model Number: TV-IL1410100-J
• Device Lot Number: FS061124-39
• 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: 04/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL (LOT# 2955810005).; AFX2 BIFURCATED STENT GRAFT (LOT# 2955810005).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male