MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; EXTENDER

Model Number	TV-EX282845-J
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504); Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft, an afx vela suprarenal, and an ovation ix extender on (b)(6) 2018.On (b)(6) 2025, during a routine follow up, a type ib endoleak from the right iliac was found.The patient is asymptomatic.An intervention is scheduled for (b)(6) 2025.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 device involved in this event will not be returned for evaluation as it remains implanted in the patient.Available patient medical records and imaging studies have been received for evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device remains implanted.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft (bsg), an afx vela suprarenal, and an ovation ix extender on (b)(6) 2018.On (b)(6) 2025, during a routine follow up, a type ib endoleak from the right iliac was found.On (b)(6) 2025 an intervention occurred with implantation of an afx2 bsg, a vela infrarenal, and an ovation ix iliac limb.The leak was resolved and the patient is doing great.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 device involved in this event will not be returned for evaluation as it remains implanted in the patient.Available patient medical records and imaging studies have been received for evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Corrections: b2: outcomes attributed to ae has been updated.B5: describe event or problem has been updated.B7: other relevant history has been updated.G3: date received by manufacturer has been updated.H6: impact code: remove code 4614.
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 type ib endoleak of the right common iliac artery is confirmed.This is consistent with the reported adverse event/incident.No contributing factors were identified.The clinical assessment also determined a type iiib endoleak of the distal main body occurred that was not in the event as reported.The type iiib endoleak was discovered during a review of the ct scan dated (b)(6) 2025.Device, user, procedure or anatomy relatedness of the complaint could not be determined.No procedure related harms were identified.The final patient status was discharged on post operative day one home in stable condition.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: date received by manufacturer has been updated.H6: medical device problem codes: remove code 4065 h6: investigation type codes: remove code 4118 h6: result code: remove code 3233 h6: conclusion code: remove code 11.

• Brand Name: OVATION IX
• Common Device Name: EXTENDER
• 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: 23761187
• Report Number: 3008011247-2025-00104
• Device Sequence Number: 9992678
• Product Code: MIH
• UDI-Device Identifier: M701TVEX282845J1
• UDI-Public: +M701TVEX282845J1/$3201031FS101917490
• 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: 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,Followup,Followup
• Report Date (Section B): 11/10/2025

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: 10/31/2020
• Device Model Number: TV-EX282845-J
• Device Lot Number: FS101917-49
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/31/2025; 02/18/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/22/2026; 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2017
• 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: AFX VELA SUPRARENAL, LOT # 1767695013; AFX2 BIFURCATED STENT GRAFT, LOT # 1703548007
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 80 YR
• Patient Sex: Male