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

Model Number TV-AB3480-E

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/01/2014

Event Type  Injury  

Event Description

An ovation prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The two month follow-up ct showed the presence of a type ia endoleak with infolding of the stent graft sealing rings, which was possibly caused by thrombus in the seal zone.As of the date of this report, there have been no additional patient sequelae reported and there is no planned re-intervention.

Manufacturer Narrative

Remains implanted.

• Brand Name: OVATION PRIME 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: 4375918
• MDR Text Key: 5240338
• Report Number: 3008011247-2014-00099
• Device Sequence Number: 1
• Product Code: MIH
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2014

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: 03/31/2017
• Device Model Number: TV-AB3480-E
• Device Catalogue Number: TV-AB3480-E
• Device Lot Number: FS021914-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2014
• 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: 75 YR