BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAMOUNT MINI GPS BILIARY STENT SYSTEM

    MDR report key: 1840902 · Received September 15, 2010

    Report

    Report Number
    2183870-2010-00150
    Event Type
    Injury
    Date Received
    September 15, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 PROCEDURE TO STENT THE RENAL ARTERY, THE STENT CAME OFF OF THE DELIVERY BALLOON. THE PARAMOUNT 5MM STENT WAS ADVANCED OVER THE WIRE TO THE LEVEL OF THE RIGHT RENAL ARTERY OSTIUM. THE ANGLE OF THE VESSEL WAS DIFFICULT AND HIGHLY CALCIFIED. AS THE STENT WAS ADVANCED IT APPEARED TO BECOME DISLODGED FROM THE BALLOON MOUNT. AS A RESULT, THE STENT WAS DEPLOYED IN THE RIGHT EXTERNAL ILIAC ARTERY. THERE WAS EXCELLENT APPOSITION OF THE STENT TO THE ARTERIAL WALL AND GOOD FLOW THROUGH THE VESSEL. NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARAMOUNT MINI GPS BILIARY STENT SYSTEM FGE EV3 INC. PMB8-5-14-80 7626700

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 6F IMA GUIDE MEDTRONIC