BEUDAMED
    FDA Recall Terminated

    Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).

    Recall: Z-0125-2015 · Initiated September 20, 2014

    Recall

    Recall Number
    Z-0125-2015
    Event Number
    69326
    Firm
    Trivascular, Inc
    FEI Number
    3008011247
    Product Code
    MIH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 20, 2014
    Posted
    November 3, 2014
    Terminated
    December 4, 2014
    Address
    3910 Brickway Blvd, Santa Rosa, CA, 95403

    Description

    Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).

    Reason

    TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure.

    Action

    Urgent Field Safety Notice letter was sent to all consignees on 9/19/14 via trackable mail system. Users are notified that TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure.

    Distribution

    International Distribution Only -- Canada, Turkey, Austria, Ireland, Belgium, Italy, Switzerland, Spain, France, and Cyprus.

    Quantity

    0 Devices