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

Model Number	TV-IL1414120-J
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	04/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
An afx2 bifurcated stent graft system and ovation ix iliac limb stent graft system were implanted to treat an abdominal aortic aneurysm.Patient returned for a follow-up approximately 10 months post-op where a ct showed the presence of a potential type iiia and/or iiib endoleak near the origin of the hypo-snorkel from the right common and right internal iliac arteries.A possible re-intervention is being planned but is currently not scheduled.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Based on the description of the event and provided medical records, clinical assessment could not definitively determine the most likely cause of the reported potential type iiia and/or iiib, due to lack of relevant medical information.It was not possible to determine the type of endoleak with the imaging provided.However, the off label use of the right internal iliac artery snorkel (concomitant use of product outside the instructions for use) and off label iliac anatomy likely contributed to the event.Procedure-related circumstance(s) are not likely to have contributed to this event.Anatomical factors were found to have likely contributed to the event.The cautionary product use conditions of multiple patent lumbar arteries is not likely to have contributed to the event.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.

• Brand Name: OVATION IX ABDOMINAL STENT GRAFT SYSTEM
• Common Device Name: ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM
• Manufacturer (Section D): TRIVASCULAR, INC.; 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 6572543
• Report Number: 3008011247-2017-00241
• Device Sequence Number: 867278
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414120J1
• UDI-Public: +M701TVIL1414120J1/$$3190425FS12041527N
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2017

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: 12/04/2018
• Device Model Number: TV-IL1414120-J
• Device Catalogue Number: TV-IL1414120-J
• Device Lot Number: FS120415-27
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR