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

Model Number TV-AB3480-E

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/03/2014

Event Type  Injury  

Event Description

An ovation prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The 54 day post-operative ct images show the presence of a type ia endoleak.A review of the imaging indicates that the aortic body stent graft was implanted lower than the intended landing zone, placing the sealing rings in a vessel diameter outside the treatment range for the device.As of the date of this report, there have been no additional patient sequelae reported and no planned reintervention.The patient will continue to be monitored.

Manufacturer Narrative

Device 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: 4375930
• MDR Text Key: 18901185
• Report Number: 3008011247-2014-00100
• 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: 12/04/2014

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: 06/12/2017
• Device Model Number: TV-AB3480-E
• Device Catalogue Number: TV-AB3480-E
• Device Lot Number: FS050914-49
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2014
• Initial Date FDA Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2014
• 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: 88 YR