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

Model Number	TV-IL1416140-J
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Stenosis (2263); Obstruction/Occlusion (2422)
Date of Event	07/07/2023
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.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.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 left limb buckled stent, stenosis and ischemia of the left common iliac artery and the additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.Device, user.Procedure or anatomy relatedness of complaint could not be determined.No procedure related harms were identified.The stenosis leading to ischemia of the proximal end of the left iliac limb graft was reported from crimping of the stent.It is unclear why this crimping occurred.The final patient status was reported as discharged home on postoperative day three.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 implanted with the alto abdominal stent graft system and one additional ovation ix iliac limb in the left iliac artery to treat an 8.5 cm abdominal aortic aneurysm (aaa) on (b)(6) 2023.During the index procedure there was an intraoperative type ia endoleak that was treated with a palmaz stent (non-endologix), there was a minimal endoleak at end of procedure.The clinical assessment of medical records and computed tomography (ct) on 08/08/2024 for previously reported mfr# 3008011247-2024-00074, identified additional information not previously reported.The clinical assessment revealed that one day post index procedure on (b)(6) 2023, there was lack of lower left limb extension pulses.A computed tomography arteriogram (cta) revealed that infrarenal angulation was 55 degrees, and the proximal end of the left iliac ovation ix stent graft was stenotic and buckled.The physician elected to implant two (2) covered stents (non endologix) bilaterally in a kissing stent technique at the level of the ovation ix iliac limb and restored flow to the lower left limb extension.The patient was discharged home in stable condition.

• 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: 20086101
• Report Number: 3008011247-2024-00094
• Device Sequence Number: 7736474
• Product Code: MIH
• UDI-Device Identifier: 00850007370268
• UDI-Public: (01)00850007370268(17)241218(10)FS121721059
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 08/08/2024

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: 12/18/2024
• Device Model Number: TV-IL1416140-J
• Device Lot Number: FS121721-59
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• 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: LOT# FS111522-52; OVATION IX ILIAC LIMB: LOT# FS040622-63; OVATION IX ILIAC LIMB: LOT# FS040723-14; OVATION IX ILIAC LIMB: LOT# FS051021-39; OVATION PRIME FILL POLYMER: LOT# FF012323-01; PALMAZ (NON-ENDOLOGIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Unknown