BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAMOUNT MINI GPS BILIARY STENT SYSTEM

    MDR report key: 1220485 · Received November 4, 2008

    Report

    Report Number
    2183870-2008-00153
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RIGHT RENAL STENOSIS PROXIMAL STENOSIS WITH INFERIOR TAKE OFF. THE STENT WAS INTRODUCED INTO ARTERY, WHERE THE GUIDE DISENGAGED AND FLIPPED THE STENT INTO THE AORTA, PULLING THE BALLOON AND STENT APART. THIS LEFT THE STENT ON THE WIRE IN THE AORTA. IT TOOK 30 MINUTES TO SNARE THE STENT AND RETRIEVE THE GUIDE, SHEATH AND STENT. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARAMOUNT MINI GPS BILIARY STENT SYSTEM FGE EV3 INC. PMB4-5-18-80 5853006

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention MEDTRONIC PK1| .014 COVERWIRE