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

Model Number TV-AB2680-D

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Aneurysm (1708)

Event Date 07/07/2016

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.

Event Description

An ovation prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.At 3 years post-operative, the patient presented with a potential aortic rupture and/or endoleak and evidence of aneurysm enlargement.Upon review of the post-operative ct imaging, there was no evidence of an aortic rupture; there was evidence of aneurysm enlargement due to a type ii endoleak from patent vessels entering the aortic sac.A re-intervention was performed to successfully treat the endoleak.As of the date of this report, there have been no additional patient sequelae reported.

• 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: 5919585
• MDR Text Key: 53658813
• Report Number: 3008011247-2016-00098
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 08/01/2016

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: 04/29/2016
• Device Model Number: TV-AB2680-D
• Device Catalogue Number: TV-AB2680-D
• Device Lot Number: FS022613-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2016
• Initial Date FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/29/2013
• 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): Required Intervention
• Patient Age: 94 YR