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

Model Number	TV-IL1412100-J
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa) on (b)(6) 2018.On (b)(6) 2019 the patient developed an occluded right limb with thrombus in the right common femoral artery aneurysm.The physician elected to perform a thrombectomy of the right internal iliac artery as well as implant unknown (non-endologix) bilateral common iliac artery stents.Then a right external iliac artery/superficial femoral artery embolectomy was performed, an open thrombectomy of the right coronary femoral artery was performed, and a viabahn (non-endologix) stent was placed from the right superficial femoral artery to below-knee popliteal artery.The final patient's status was reported as stable.
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 right common iliac artery occlusion and additional endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.No contributing factors were identified.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.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: 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: 22913272
• Report Number: 3008011247-2025-00074
• Device Sequence Number: 9184765
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1412100J1
• UDI-Public: +M701TVIL1412100J1/$$3200505FS032817271
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• 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
• Report Date (Section B): 08/06/2025

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: 05/05/2020
• Device Model Number: TV-IL1412100-J
• Device Lot Number: FS032817-27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• 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: CUSTOMSEAL KIT FILL POLYMER, LOT # FF120417-01.; OVATION IX ILIAC LIMB, LOT # FS041416-42.; OVATION IX ILIAC LIMB, LOT # FS121117-68.; OVATION IX MAIN BODY, LOT # FS090717-36.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male