MAUDE Adverse Event Report: ENDOLOGIX OVATION IX; ILIAC LIMB

Model Number	TV-IL1410140-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Occlusion (1984); Thrombus (2101); Stenosis (2263)
Date of Event	02/16/2020
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.
Event or Problem Description
The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately 2.5 years post initial procedure, occlusion of the right limb graft and thrombus and stenosis of the left limb graft was identified by a ct (computed tomography) during a routine follow up.The patient was reported as doing good and is currently be monitored.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.The right iliac stent occlusion and the left iliac stent stenosis event are confirmed.The superior stent margin of the left iliac limb was 3.2mm above the right however, without comparative imaging it cannot be determine if this was user error at implant or stent movement.Device, user, procedure or anatomy relatedness of this event could not be determined.Procedure related harms for this complaint could not be determined.The final patient status was reported as doing good with no intervention scheduled at this time.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this event and similar events in the event further investigation is needed.Corrections: h6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10027166
• Report Number: 3008011247-2020-00063
• Device Sequence Number: 2813664
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1410140J1
• UDI-Public: +M701TVIL1410140J1/$$3190224FS05151520F
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

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: 02/24/2019
• Device Model Number: TV-IL1410140-J
• Device Catalogue Number: TV-IL1410140-J
• Device Lot Number: FS051515-20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ILIAC LIMB, FS042516-70; MAIN BODY STENT GRAFT, FS112816-09; POLYMER, FF051517-02
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR