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

Model Number	TV-IL1416140-J
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.H3 other text : device remains implanted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.During the initial implant procedure, the contralateral leg to the alto main body did not completely fill with polymer.The physician successfully utilized the cross-over channel for gate access and the procedure was completed with no impact to the patient.This event was previously reported under 3008011247-2022-00104.Now, approximately one and a half (1.5) years post initial procedure, during follow up the iliac limb stent graft was found to have occluded on an unknown date.The patient is currently being monitored while an intervention is being discussed.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.During the initial implant procedure, the contralateral leg to the alto main body did not completely fill with polymer.The physician successfully utilized the cross-over channel for gate access and the procedure was completed with no impact to the patient.This event was previously reported under 3008011247-2022-00104.Now, approximately one and a half (1.5) years post initial procedure, during follow up the iliac limb stent graft was found to have occluded on an unknown date.The patient is currently being monitored while an intervention is being discussed.Additional information: it was reported that a pre angiogram noted a stenotic area at the proximal right portion of the right alto limb.The physician elected to implant an ovation ix iliac limb stent graft on the right side followed by two (2) i-cast (non-endologix) balloon expandable stents on each side of the alto main body to resolve this event.The patient was reported as doing well post secondary repair.
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.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/or medical imaging received by endologix shows that the right common iliac limb occlusion and additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.It was reported that the contralateral left limb did not completely polymer fill at the index procedure.It is unclear if this contributed to the reported events.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms could not be determined.The final patient status was reported as doing well.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: b2: outcomes attributed to adverse events has been updated.B5: describe event or problem has been updated.G3: awareness date has been updated.H6: health effect - impact code: remove code 4614.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: 18953800
• Report Number: 3008011247-2024-00028
• Device Sequence Number: 8161598
• Product Code: MIH
• UDI-Device Identifier: 00850007370268
• UDI-Public: (01)00850007370268(17)250330(10)FS032922-47
• 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: 2022
• 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): 02/27/2024

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: 03/30/2025
• Device Model Number: TV-IL1416140-J
• Device Lot Number: FS032922-47
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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 #: FS052622-61.; OVATION IX ILIAC LIMB, LOT #: FS041822-46.; OVATION PRIME FILL POLYMER, LOT #: FF011322-01.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female