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

Model Number	TV-IL1422160-J
Medical Device Problem Codes	Migration (4003); Lack of Effect (4065)
Health Effect - Clinical Codes	Abdominal Pain (1685); Ruptured Aneurysm (4436); Clinical Endoleak (4843)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2025 with the implant of an alto abdominal stent graft system and an ovation ix extender.The patient presented emergently on (b)(6) 2025 with abdominal pain and a ruptured aneurysm.Reportedly the ovation ix limb pulled back into the aorta causing a type ib endoleak in the right common iliac artery.Reintervention was completed on (b)(6) 2025 with the implant of another ovation ix limb to extend to the right hypogastric.The type ib endoleak on the right side was sealed.The patients abdominal pain subsided and was symptom free.One week later on (b)(6) 2025 the patient was brought back in to complete an extension on the left common iliac artery (lcia).There was no endoleak present in the lcia before the procedure.The physician elected to implant an ovation ix limb to extend the lcia to the left hypogastric as a preventative measure.The final patient status was reported to be well post-secondary procedures.
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies have been requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
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 medical imaging received by endologix found the type ib endoleak of the right common iliac artery (rcia) and additional endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest cranial migration of 15 mm occurred in the rcia stent that was not included in the event as reported.The cranial migration was discovered during review of the computed tomography scan dated 28 october 2025.Progressive infrarenal angulation resulted in 15 mm of cranial migration of the right iliac limb.This migration caused poor stent-to-wall apposition, leading to a type ib endoleak of the rcia.The most likely causation is anatomy related due to the aortic remodeling.No procedure related harms were identified.The final patient status was reported as discharged to 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: g3: awareness date ¿ updated.H6: medical device problem codes ¿ remove code 4065.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 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 medical imaging received by endologix found the type ib endoleak of the right common iliac artery (rcia) and additional endovascular procedure complaints are confirmed; however, the investigation was unable to identify any evidence of aortic rupture, therefore the report of rupture is refuted.This is moderately consistent with the reported adverse event/incident.The clinical evaluation did find reasonable evidence to suggest cranial migration of 15 mm occurred in the rcia stent that was not included in the event as reported.The cranial migration was discovered during review of the computed tomography scan dated (b)(6) 2025.Progressive infrarenal angulation resulted in 15 mm of cranial migration of the right iliac limb.This migration caused poor stent-to-wall apposition, leading to a type ib endoleak of the rcia.The most likely causation is anatomy related due to the aortic remodeling.No procedure related harms were identified.The final patient status was reported as discharged to 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: addtl mfg narrative - updated h6: health effect ¿ clinical code ¿ remove code 4436.

• 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: 23618811
• Report Number: 3008011247-2025-00101
• Device Sequence Number: 15697635
• Product Code: MIH
• UDI-Device Identifier: 00850007370350
• UDI-Public: (01)00850007370350(17)280213(10)FS021125-16
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup,Followup
• Report Date (Section B): 10/28/2025

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 Model Number: TV-IL1422160-J
• Device Lot Number: FS021125-16
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 11/21/2025; Not provided
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/16/2025; 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2025
• 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: ALTO MAIN BODY (LOT# FS021424-18); CUSTOMSEAL KIT FILL POLYMER (LOT# FF102824-01); OVATION IX EXTENDER (LOT# FS041725-02); OVATION IX ILIAC LIMB (LOT# FS021825-14)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male