BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

    MDR report key: 2830544 · Received November 1, 2012

    Report

    Report Number
    1820334-2012-00524
    Event Type
    Death
    Date Received
    November 1, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 4, 2012
    Manufacturer
    COOK, INC.
    Product Code
    FGE
    PMA / PMN Number
    K080037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE UNKNOWN AS LOT NUMBER IS UNKNOWN. EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT HAD A ZILVER STENT PLACED IN HER LEFT EXTERNAL ILIAC ARTERY ON (B)(6) 2012, TO TREAT SOME DISEASE THERE. SEVEN DAYS LATER ON (B)(6) 2012, THE PATIENT UNDERWENT AN EVAR PROCEDURE TO TREAT HER ABNORMAL ANEURYSM. THE EVAR EQUIPMENT USED WAS ALL ENDOVASCULAR PROSTHESES OF ANOTHER MANUFACTURE. WHEN THE OTHER MANUFACTURER'S EVAR EQUIPMENT WAS REMOVED, IT SOMEHOW BECAME CAUGHT ON THE ZILVER STENT. AFTER WORKING FOR AWHILE TO REMOVE THE OTHER MANUFACTURER'S EQUIPMENT, THE ILIAC ARTERY WAS TORN. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM TO TRY AND REPAIR THE ARTERY, HOWEVER, THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death