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

Model Number	TV-EX282845-J
Medical Device Problem Codes	Off-Label Use (1494); Separation Problem (4043)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	01/26/2026
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 (bsg), an afx vela suprarenal, and two ovation ix extenders on(b)(6) 2019.On (b)(6) 2026, during a routine follow up, it was discovered that there was separation of the ovation ix limb from the left iliac causing a type ib endoleak.On (b)(6) 2026 the physician elected to implant an ovation ix iliac limb to bridge the left common iliac separation between the existing ovation ix iliac limb and afx2 bsg device limb.Then a new afx2 bsg was implanted to help bridge and seal the iliac together.Then an ovation ix extender was placed on the right iliac.Th endoleak was resolved, the patient was stable and left the hospital the next day.
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 have been received and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted upon completing of clinical evaluation.
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.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 ib endoleak complaint is unconfirmed.The implant separation (type iiia endoleak) and additional endovascular procedure complaints are confirmed.This is moderately consistent with the reported adverse event/incident.The initial procedure is off label due to concomitant product usage (ovation limb) that is not compatible with the afx system.Per the device ifu, the safety and effectiveness of other stent or stent-graft devices used in conjunction with the afx2 system have not been established; therefore, this concomitant usage likely contributed to the implant separation and type iiia endoleak.The complaint is likely user related.No procedure related harms were identified.The final patient status was reported as discharged home on postoperative day one 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: b5: describe event or problem has been updated.B6: relevant tests and lab data has been updated.G3: date received by manufacturer has been updated.H6: investigation type codes: remove code 4118 h6: result code: remove code 3233 h6: conclusion code: remove code 11.
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 two ovation ix extenders on (b)(6) 2019.On (b)(6) 2026, during a routine follow up, it was discovered that there was separation of the ovation ix limb from the left iliac causing a type ib endoleak.On (b)(6) 2026 the physician elected to implant an ovation ix iliac limb to bridge the left common iliac separation between the existing ovation ix iliac limb and afx2 bsg device limb.Then a new afx2 bsg was implanted to help bridge and seal the iliac together.Then an ovation ix extender was placed on the right iliac.The endoleak was resolved, the patient was stable and left the hospital the next day.

• 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: 24402178
• Report Number: 3008011247-2026-00004
• Device Sequence Number: 8224114
• Product Code: MIH
• UDI-Device Identifier: M701TVEX282845J1
• UDI-Public: +M701TVEX282845J1/$$3210831FS08271841
• 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: 2019
• 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): 01/26/2026

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 Expiration Date: 08/31/2021
• Device Model Number: TV-EX282845-J
• Device Lot Number: FS082718-41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2018
• 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 #2271828015; AFX2 BIFURCATED STENT GRAFT, LOT # 1737268005; OVATION IX EXTENDER, LOT #FS022218-72
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female