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

Model Number	TV-IL1410100-J
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Thrombosis/Thrombus (4440)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented emergently on (b)(6) 2024, with a cold leg and an abdominal aortic aneurysm (aaa).Reportedly, the patient was not taking their blood thinners.The patient was treated for the aaa with the implant of the alto abdominal stent graft system.It was noted that there was significant external iliac stenosis and the physician treated this with the implant of a non-endologix balloon expandable stent and subsequently the artery perforated.This cause the patient to code.An additional ovation ix iliac limb (10x100mm) was implanted.The perforation was covered and blood pressure returned to normal.The physician reported on 26 september 2024, that the graft has thrombosed and the patient is being monitored; however, is expected to expire.
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.
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 perforation of the left iliac artery complaint is confirmed.The thrombosis leading to occlusion of the aortic graft complaint is confirmed.This is consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms identified are abnormal blood loss and hemodynamic instability.It was reported that the left iliac artery ruptured when treated with a balloon expandable stent.This led to large volume blood loss and hemorrhagic shock which likely contributed to the hemodynamic instability.Reportedly, the patient had a history of severe peripheral arterial disease which may have contributed to the left iliac artery rupture however, this could not conclusively be determined.It was reported that there was an inability to restart blood thinners postoperatively, likely due to hemorrhage, which may have contributed to the aortic occlusion, but this could not be conclusively determined.The final patient status is reported as transitioned into hospice care, however, is expected to expire.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: investigation finding codes - remove code 3233 h6: investigation conclusion codes - remove code 11.

• 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: 20385536
• Report Number: 3008011247-2024-00107
• Device Sequence Number: 8037912
• Product Code: MIH
• UDI-Device Identifier: 00850007370121
• UDI-Public: (01)00850007370121(17)261201(10)FS113023-66
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/26/2024

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 Model Number: TV-IL1410100-J
• Device Lot Number: FS113023-66
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2023
• 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: ALTO MAIN BODY (LN FS022824-65).; NON-ENDOLOGIX BALLOON EXPANDABLE STENT.; OVATION IX ILIAC LIMB (LN FS080923-63).; OVATION IX ILIAC LIMB (LN FS110223-28).; OVATION PRIME FILL POLYMER (LN FF010424-02).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male