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

Model Number	TV-IL1418120-J
Medical Device Problem Codes	Migration (4003); Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
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 will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was treated for a large abdominal aortic aneurysm with a right common iliac aneurysm on (b)(6) 2023 with the implant of an alto abdominal stent graft system, and an additional ovation ix iliac limb in both the right and left iliacs.It was reported on (b)(6)2023, that a routine follow-up computed tomography (ct) scan identified a type ib endoleak of the left common iliac artery.Reintervention is in the pipeline for (b)(6) 2023.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.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.Endologix could not perform an evaluation of the device as the device remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the type ib endoleak of the left common iliac artery and additional endovascular procedure (ovation limb 07 february 2024) complaints are confirmed.This is consistent with the reported adverse event/incident.The type ib endoleak of the left common iliac artery was anatomy related.There was bilateral 90-degree angulation in both iliacs pre-index procedure.This likely caused the cranial migration of the left limb of approximately 20mm.The cranial migration likely caused the type ib endoleak of the left common iliac artery.Procedure related harms for this complaint were right limb ischemia and additional surgical procedure (right femoral popliteal bypass) occurred immediately post operatively on (b)(6) 2023.The final patient status is reported as completely normal post intervention.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.
Event or Problem Description
The patient was treated for a large abdominal aortic aneurysm with a right common iliac aneurysm on (b)(6) 2023 with the implant of an alto abdominal stent graft system, and an additional ovation ix iliac limb in both the right and left iliacs.Reportedly, a few weeks post-alto implant the patient had a reintervention after presenting with cold leg, after a fem-pop bypass in their right suprarenal femoral artery.It was reported on (b)(6) 2023, that a routine follow-up computed tomography (ct) scan identified a type ib endoleak of the left common iliac artery.Additionally, an ovation ix iliac limb may have shifted.Reintervention is now in the pipeline for (b)(6) 2024.After the initial report, reintervention was completed on (b)(6) 2024, with the implant of an ovation ix extender.The type ib endoleak was successfully sealed.Patient status was completely normal post-reintervention.Additionally, clinical assessment identified that the reported fem-pop bypass in the right suprarenal femoral artery occurred on (b)(6) 2023, three and a half hours post-procedure.This was discovered during review of the operative note (second procedure) dated (b)(6) 2023.

• 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: 18323537
• Report Number: 3008011247-2023-00203
• Device Sequence Number: 17954652
• Product Code: MIH
• UDI-Device Identifier: 00850007370299
• UDI-Public: (01)00850007370299(17)250218(10)FS021722-41
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/08/2023

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: 02/18/2025
• Device Model Number: TV-IL1418120-J
• Device Lot Number: FS021722-41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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 (LN FS071923-10); OVATION IX ILIAC LIMB (LN FS030923-35); OVATION IX ILIAC LIMB (LN FS080922-74); OVATION IX ILIAC LIMB (LN FS100422-52); OVATION PRIME FILL POLYMER (LN FF072123-01)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male