MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; MAIN BODY

Model Number	TV-AB2380-J
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with the ovation ix stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately five (5) years post initial procedure, during a routine follow up, the patient presented with an aneurysm that is still growing.The patient is asymptomatic but aaa is now over 5cm.The patient is being monitored while an intervention is being discussed.Additionally, an internal clinical assessment determined there was evidence to reasonably suggest a type 1a endoleak occurred that was not included in the event as reported.The type 1a endoleak was discovered during review of the computed tomography (ct) scan dated on (b)(6) 2025.
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 are not available.Imaging studies have been received for further evaluation by the clinical specialist.A follow-up report will be submitted upon completion of clinical analysis.
Additional Manufacturer Narrative
The reported 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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 type 1a endoleak and aneurysm enlargement of 8 mm are confirmed.This is consistent with the reported adverse event/incident.The complaint is likely anatomy related.Proximal neck calcification likely caused poor apposition resulting in the type 1a endoleak.Calcification at the aortic neck is considered cautionary product use.No procedure related harms could be determined.The final patient status was reported as being monitored while intervention options are being discussed.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.Corrections: b6: relevant tests and lab data has been updated.G3: awareness date has been updated.H6: investigation type codes: remove code 4118.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.
Additional Manufacturer Narrative
The reported 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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 type 1a endoleak and aneurysm enlargement of 8 mm are confirmed.This is consistent with the reported adverse event/incident.The clinical assessment determined that there was evidence to reasonably suggest a type 2 endoleak (non-device related) from the inferior mesenteric artery occurred that was not included in the event as reported.The type 2 endoleak was discovered during review of ct scan dated (b)(6) 2021.The complaint is likely anatomy related.Proximal neck calcification likely caused poor apposition resulting in the type 1a endoleak.Calcification at the aortic neck is considered cautionary product use.No procedure related harms could be determined.The final patient status was reported as being monitored while intervention options are being discussed.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.Corrections: b6: relevant tests and lab data has been updated.G3: awareness date has been updated.H10/h11: additional manufacturer narrative/corrected data has been updated.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• 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: 23758470
• Report Number: 3008011247-2025-00102
• Device Sequence Number: 21365182
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380J1
• UDI-Public: +M701TVAB2380J1/$$3230313FS05122016
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 11/24/2025

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: 05/13/2023
• Device Model Number: TV-AB2380-J
• Device Lot Number: FS051220-16
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 02/05/2026; 02/13/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/12/2026; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2020
• 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: OVATION IX ILIAC LIMB, LOT # FS031820-18.; OVATION IX ILIAC LIMB, LOT # FS032320-16.; OVATION PRIME FILL POLYMER, LOT # FF041320-01.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Unknown