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

Model Number	TV-IL1416120-J
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with the implant of the ovation ix abdominal stent graft system.Approximately (4) four years post-implant right limb thrombosis was identified.Reintervention is planned for an open thrombectomy with relining of the limb and stenting of the proximal external iliac artery, but surgery has not been scheduled.The patient is currently being monitored.
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.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with the implant of the ovation ix abdominal stent graft system.Approximately (4) four years post-implant right limb thrombosis was identified.Reintervention is planned for an open thrombectomy with relining of the limb and stenting of the proximal external iliac artery, but surgery has not been scheduled.The patient is currently being monitored.Additional information: the patient underwent a re-intervention procedure in which the physician opted for the implantation of an ovation ix iliac limb.The final patient status was reported as discharged home on postoperative day one.
Additional Manufacturer Narrative
The reported 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 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 medical records and/or medical imaging received by endologix shows the ovation ix, right limb thrombus with the additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The patient has a history of clot formation including pulmonary embolism and right upper extremity deep vein thrombosis.The discharge summary stated the patient was taken off blood thinners by the pulmonologist one (1) month prior to the reported event.It is likely this contributed to the right limb thrombus.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.The final patient status was reported as discharged home on postoperative day one.No additional investigation of this reported 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 events/incidents.B5: describe event or problem ¿ updated.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: 16665569
• Report Number: 3008011247-2023-00040
• Device Sequence Number: 6072131
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1416120J1
• UDI-Public: +M701TVIL1416120J1/$$3201130FS112017539
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 03/11/2023

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: 11/30/2020
• Device Model Number: TV-IL1416120-J
• Device Catalogue Number: TV-IL1416120-J
• Device Lot Number: FS112017-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2018
• 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: OVATION IX ILIAC LIMB (B)(6); OVATION IX MAIN BODY (B)(6); OVATION PRIME FILL POLYMER (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Unknown