MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; ILIAC LIMB STENT GRAFT (LEFT)

Model Number	TV-IL1418140-J
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2025 with the implant of an alto abdominal stent graft system.It was reported that the procedure was performed for a fusiform aneurysm with a long neck and narrow access vessels.The alto main body was deployed via left access.The contralateral leg of the alto main body was oriented to the anterior/posterior direction, resulting in a cross-legged (ballerina) configuration.The customseal polymer fill was delivered without any issues.Contralateral cannulation was achieved successfully in approximately four minutes.The ovation ix iliac limb stent graft was deployed in the right common iliac artery (cia), followed by touch-up using the integrated balloon 14 minutes later.Next the other ovation ix iliac limb stent graft was deployed in the left cia, followed by balloon touch-up.The procedure was completed with no endoleaks or flow delays confirmed.Routine follow-up approximately three months later on (b)(6) 2026 conducted a computed tomography (ct) scan that revealed thrombotic occlusion of the right cia limb (from the proximal to the distal end) as well as occlusion of the proximal section of the left cia limb.There was no discrepancy in the positioning height of the left and right ovation ix limbs.Reintervention was completed on (b)(6) 2026.First a thrombectomy was performed via the right femoral artery.The physician then elected to implant (non-endologix) 14mm x 4cm bare metal stents bilaterally, extending approximately 5mm proximally from the legs.An angiography was conducted that confirmed adequate stent graft patency.Per the physician's discretion, balloon touch-up was not performed, and the procedure was concluded.The final patient status was not provided.
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Pre-planning and computed tomography imaging studies have been received.Patient medical records 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.H3 other text : device remains implanted.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB STENT GRAFT (LEFT)
• 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: 25034415
• Report Number: 3008011247-2026-00037
• Device Sequence Number: 9039540
• Product Code: MIH
• UDI-Device Identifier: 00850007370305
• UDI-Public: (01)00850007370305(17)280821(10)FS081825-35
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120006
• 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: Other,Foreign,Health Professional,Distributor
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: TV-IL1418140-J
• Device Lot Number: FS081825-35
• 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: 05/21/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2025
• 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: ALTO MAIN BODY (LOT# FS051225-28); CUSTOMSEAL KIT (LOT# FF021825-01); OVATION IX ILIAC LIMB (RIGHT) (LOT# FS021125-15)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male