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

Model Number TV-AB3480-J

Device Problems Material Invagination (1336); Malposition of Device (2616)

Patient Problem Aneurysm (1708)

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.

Event Description

An ovation ix abdominal stent graft was implanted to treat an abdominal aortic aneurysm.The post-operative ct showed the presence of a type ia endoleak likely due to graft in-folding at the sealing ring and secondary ring.A balloon expandable stent was implanted which did not resolve the endoleak.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.

• Brand Name: OVATION IX ABDOMINAL STENT GRAFT SYSTEM
• Type of Device: ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM
• Manufacturer (Section D): TRIVASCULAR, INC.; 3910 brickway blvd.; santa rosa CA 95403
• Manufacturer (Section G): TRIVASCULAR, INC.; 3910 brickway blvd.; santa rosa CA 95403
• Manufacturer Contact: alexis weil ; 3910 brickway blvd.; santa rosa, CA 95403 ; 7075438835
• MDR Report Key: 6097888
• MDR Text Key: 59715129
• Report Number: 3008011247-2016-00120
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3190309FS011816159
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2016

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
• Device Operator: Physician
• Device Expiration Date: 01/18/2019
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS011816-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PALMAZ
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR