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

Model Number	TV-IL1410100-J
Medical Device Problem Codes	Off-Label Use (1494); Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Medical records were received; however medical imaging was not provided.Endologix made three good faith efforts to retrieve reported adverse event/incident-related medical imaging.However, the user facility did not respond to requests for this information.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 received by endologix found the left iliac artery occlusion and additional endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation shows reasonable evidence to suggest the patient had a history of aortoiliac occlusive disease (aiod) with bilateral femoral artery stenosis which likely contributed to the left iliac artery occlusion.The clinical evaluation also shows reasonable evidence to suggest a left femoral cutdown with endarterectomy at the index procedure likely contributed to thrombus formation and subsequent iliac occlusion.Therefore, the most likely causation of the left iliac artery occlusion and additional endovascular procedures are procedure and anatomy related.Procedure related harms related for this complaint could not be determined with the medical records available for review.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The procedure is outside the indications of use (off-label) due to the use of adjunctive devices (ovation ix limbs) not compatible with afx system per the ifu.The final patient status was reported as discharged to hospice facility on postoperative day twenty-three for palliative care.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.H3 other text: device remains implanted.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2025 with the implant of an afx2 bifurcated stent graft (bsg).Reportedly the patient had extensive bi-lateral iliac disease as well with calcium occlusion.An ovation ix limb was placed on the right-side post aaa repair and the external iliac was ruptured.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.The surgical procedure was converted to an open repair in order to fix the distal external into the femoral with a graft/patch repair.Patient status was stable and closed.Approximately 1 hour later before leaving the operating room the patient became unstable, and pressure dropped.The surgeon re-opened the patient incision to investigate and saw an iliac tear higher up that required additional ovation ix limbs overlapping into the afx2 bsg limb.This covered the iliac tear and the patient was stabilized.The final patient status was reportedly stable.(initial mdr#3008011247-2025-00047) additional findings discovered during the clinical investigation identified that the patient returned to the operating room three days later to have a hemodialysis catheter placed and removal of right femoral packing, as well as removal of the brachial sheath with thrombectomy and reconstruction.(captured on follow-up mdr#3008011247-2025-00047) additional findings discovered during the clinical investigation also identified that the patient returned to the operating room seven days post initial procedure on (b)(6) 2025 due to a left iliac occlusion that was treated with a thrombectomy and fem-fem bypass.The superficial femoral artery (sfa) is chronically occluded.

• 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: 22993973
• Report Number: 3008011247-2025-00078
• Device Sequence Number: 8914418
• Product Code: MIH
• UDI-Device Identifier: 00850007370428
• UDI-Public: (01)00850007370428(17)260623(10)FS062223-30
• 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: 2025
• 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): 08/13/2025

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: 06/23/2026
• Device Model Number: TV-IL1410100-J
• Device Lot Number: FS062223-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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: AFX2 BIFURCATED STENT GRAFT (LOT# 2849432013); AFX2 VELA SUPRARENAL (LOT# 2841830009); OVATION IX ILIAC LIMB (LOT# FS062223-30); OVATION IX ILIAC LIMB (LOT# FS062724-35)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female