MAUDE Adverse Event Report: TRIVASCUALR, INC OVATION IX AORTIC BODY STENT GRAFT SYSTEM; ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM

Model Number	TV-IL1418140-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	03/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.A routine follow-up angio was completed approximately 1 month post-op showing a possible type ib endoleak.The physician elected to complete a re-intervention implanting an ovation limb; patient's right, which successfully resolved the reported endoleak.The patient was reported as well and will continue to be monitored.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the reported inadequate stent graft patency and loss of seal was found to be unknown/undetermined due to the lack of medical records and imaging surrounding the event.Unable to determine procedure-related, anatomy-related, and user-related issues, off label, or cautionary product use conditions.The source of the endoleak could also not be determined based on the images given.The final patient disposition was reported as monitored and no additional negative patient sequelae reported.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.(b)(4).

• Brand Name: OVATION IX AORTIC BODY STENT GRAFT SYSTEM
• Common Device Name: ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM
• Manufacturer (Section D): TRIVASCUALR, INC; 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 6474434
• Report Number: 3008011247-2017-00039
• Device Sequence Number: 605746
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418140J1
• UDI-Public: +M701TVIL1418140J1/$$3160811FS07311542Q
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2017

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: Physician
• Device Expiration Date: 08/11/2016
• Device Model Number: TV-IL1418140-J
• Device Catalogue Number: TV-IL1418140-J
• Device Lot Number: FS073115-42
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 04/08/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other