MAUDE Adverse Event Report: TRIVASCULAR OVATION STENT GRAFT SYSTEM; OVATION ENDOGRAFT

Device Problems Filling Problem (1233); Sticking (1597)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/14/2018

Event Type  Injury  

Event Description

Patient has an abdominal aortic aneurysm, she was scheduled for endovascular repair of intrarenal aortic aneurysm repair with ovation endograft.The graft has 2 polymer rings which are supposed to get filled with the polymer which has an automatic injector.The rings did not fill and basically, there was no seal on the proximal end of the endograft.Then the contralateral limb which should open after unsheathing did not open up.The entire graft was constrained without any external pressure.This caused a significant type ia endoleak and we were not able to even find the gate by the antegrade or retrograde approach.Dates of use: (b)(6) 2018.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: OVATION STENT GRAFT SYSTEM
• Type of Device: OVATION ENDOGRAFT
• Manufacturer (Section D): TRIVASCULAR; santa rosa CA 95403
• MDR Report Key: 7533906
• MDR Text Key: 109042959
• Report Number: MW5077365
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 91 YR
• Patient Weight: 72