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

Model Number TV-AB3480-E

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/09/2015

Event Type  Injury  

Event Description

An ovation prime abdominal stent graft was implanted to treat an abdominal aortic aneurysm in a patient with a juxtarenal angle outside the indications for use for the device.The stent graft was positioned and deployed as expected.The final angiogram showed the presence of a type ia endoleak that was not resolved following ballooning and the placement of a stent.As of the date of this report, there have been no additional sequelae reported and the patient will continue to be monitored.

Manufacturer Narrative

Remains implanted.

Manufacturer Narrative

It was reported that the patient returned to the hospital on the weekend of (b)(6) with abdominal pain and a ruptured aneurysm.The patient was converted to open surgical repair to explant the stent graft.As of the date of this report, the patient is reported as being in stable condition and there have been no additional sequelae reported.Not released by implante site for eval.

• 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: 4375861
• MDR Text Key: 5119062
• Report Number: 3008011247-2014-00097
• 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,Followup
• Report Date: 01/09/2015

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: 07/11/2017
• Device Model Number: TV-AB3480-E
• Device Catalogue Number: TV-AB3480-E
• Device Lot Number: FS052214-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/11/2014
• 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
• Treatment: PALMAZ STENT (X2)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 84 YR