BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    MDR report key: 1911728 · Received November 18, 2010

    Report

    Report Number
    2183870-2010-00179
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 12, 2010
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A STENTING PROCEDURE ON THE SUBCLAVIAN, THE PROTEGE EVERFLEX STENT JUMPED AND WAS DEPLOYED IN THE AORTA. IT DEPLOYED ACROSS THE AORTA INTO THE SUBCLAVIAN. A SECOND STENT HAD TO BE DEPLOYED. NO INJURY TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT FGE EV3 INC. PRB35-08-030-120 9179144

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention