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

Model Number TV-AB3480-I

Device Problems Material Invagination (1336); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Aneurysm (1708)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.

Event Description

An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.At approximately 1m post- op, a completed ct revealed a potential type ia endoleak.In addition, infolding at the first sealing ring was observed.The physician elected to continue monitoring the patient.

• Brand Name: OVATION IX AORTIC BODY STENT GRAFT SYSTEM
• Type of Device: ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURSYM
• Manufacturer (Section D): TRIVASCULAR INC.; 3910 brickway blvd.; santa rosa CA 95403
• Manufacturer Contact: alexis weil ; 3910 brickway blvd.; santa rosa, CA 95403 ; 7075438835
• MDR Report Key: 6455732
• MDR Text Key: 71575806
• Report Number: 3008011247-2017-00037
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480I1
• UDI-Public: +M701TVAB3480I1/$$3190706FS05041626A
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2017

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
• Device Operator: Physician
• Device Expiration Date: 07/06/2019
• Device Model Number: TV-AB3480-I
• Device Catalogue Number: TV-AB3480-I
• Device Lot Number: FS050416-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2017
• Initial Date FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 86 YR