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

Model Number	TV-IL1422120-J
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa) on (b)(6) 2024.During routine surveillance on (b)(6) 2024, a type 3a endoleak and suspected component separation on the left iliac limbs were detected.The patient is stable and currently being monitored while an intervention is being discussed.
Additional Manufacturer Narrative
The devices involved in this event will not be returned.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.H3 other text : device remains implanted.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in accordance with endologix operating procedures and work instructions.Where possible, it is endologix's practice to make at least three good-faith efforts to retrieve a device related to the reported adverse event/incident, as well as to obtain relevant 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 confirmed that the device was properly manufactured and released in accordance with the device master record.The review confirmed that no manufacturing or processing non-conformities were identified that would have contributed to the reported adverse event/incident.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 the medical records and/or medical imaging received by endologix shows that the ovation ix, type iiia endoleak complaint is unconfirmed.However, the additional endovascular procedure is confirmed.This is moderately consistent with the reported adverse event/incident.The left iliac limb was highly tortuous, which likely contributed to the reported event; however, this could not be conclusively determined.Procedure-related harms, device-related factors, user-related issues, or anatomical considerations regarding this complaint could not be determined based on the medical records available for review.The final patient status was not reported.No further 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: b2: outcomes attributed to adverse events ¿ updated.G3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
Event or Problem Description
The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa) on (b)(6) 2024.During routine surveillance on (b)(6) 2024, a type 3a endoleak and suspected component separation on the left iliac limbs were detected.The patient is stable and currently being monitored while an intervention is being discussed.Additional information: on (b)(6) 2024, a re-intervention was performed involving the implantation of an ovation ix iliac limb.It was reported that the type 3a endoleak was successfully sealed, and the patient was discharged.

• 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: 19652090
• Report Number: 3008011247-2024-00075
• Device Sequence Number: 12448934
• Product Code: MIH
• UDI-Device Identifier: 00850007370336
• UDI-Public: (01)00850007370336(17)261107(10)FS110623-17
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/11/2024

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-IL1422120-J
• Device Lot Number: FS110623-17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2023
• 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 LOT# FS101723-01.; OVATION IX ILIAC LIMB LOT# FS051022-63.; OVATION IX ILIAC LIMB LOT# FS111821-68.; OVATION PRIME FILL POLYMER LOT# FF100323-03.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male