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

Model Number	TV-IL1414140-J
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Ischemia (1942); Obstruction/Occlusion (2422)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implantation of the alto abdominal aortic aneurysm stent system on (b)(6) 2022.On (b)(6) 2024, it was reported through a clinical study that the patient presented with right hip and leg claudication and was found to have an occlusion of the right iliac artery.The patient underwent re-intervention, which included a right iliac thrombectomy and a femoral-femoral bypass.The final patient status remains unknown.The final patient status was not made available to endologix.
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.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in accordance with endologix's operating procedures and work instructions.Where possible, endologix makes at least three good-faith efforts to retrieve the device related to the reported adverse event/incident, as well as the associated medical records and imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination required 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 could have contributed to the reported adverse event/incident.The device was not returned to endologix for evaluation, as it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of the medical records and/or imaging received by endologix shows that the right iliac occlusion with ischemia (claudication) and an additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.No procedure related harms for this complaint were identified.The final patient status was reported to be discharged home on the second post operative day.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: 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: 19817598
• Report Number: 3008011247-2024-00085
• Device Sequence Number: 8891715
• Product Code: MIH
• UDI-Device Identifier: 00850007370220
• UDI-Public: (01)00850007370220(17)250615(10)FS061522-15
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 06/15/2025
• Device Model Number: TV-IL1414140-J
• Device Lot Number: FS061522-15
• 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: 07/09/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• 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# FS050222-06.; OVATION IX ILIAC LIMB LOT# FS061622-12.; OVATION PRIME FILL POLYMER LOT# FF021622-03.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male