MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; MAIN BODY

Model Number	TV-AB2380-J
Medical Device Problem Codes	Leak/Splash (1354); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Stenosis (2263)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient and will not be returned for evaluation.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.On (b)(6) 2018, the patient presented with claudication.On (b)(6) 2018, thrombus in the limbs of the ovation graft was treated with litic therapy to lyse the thrombus.Additionally, two iliac limb extensions were placed above the previously placed limbs to a level of approximately 15mm below the secondary ring.The following day the patient was reported to be doing fine.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Clinical assessment was performed based off the provided medical records.The reported claudication, and bilateral occlusion (aortic occlusion) is not confirmed, however, there are bilateral stents within the aortic portion of the system that are patent.User and procedure related harms could not be determined.The final patient status was reported as doing well.The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8025051
• Report Number: 3008011247-2018-00238
• Device Sequence Number: 11036159
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380J1
• UDI-Public: +M701TVAB2380J1/$$3210622FS061918426
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2021
• Device Model Number: TV-AB2380-J
• Device Catalogue Number: TV-AB2380-J
• Device Lot Number: FS061918-42
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 03/27/2019
• 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: OVATION IX ILIAC LIMB (LN FS042418-17).; OVATION IX ILIAC LIMB (LN FS070518-20).; OVATION IX ILIAC LIMB (LN FS042418-17); OVATION IX ILIAC LIMB (LN FS070518-20)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR