BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RACER BILIARY STENT SYSTEM

    MDR report key: 1071331 · Received July 8, 2008

    Report

    Report Number
    2953200-2008-00507
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 12, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K032768
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (REQUIRED SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    A 4 MM DIAMETER X 12 MM LENGTH RACER BILIARY STENT SYSTEM WAS INSERTED TO TREAT A RIGHT RENAL ARTERY LESION WITH 70% STENOSIS. THE PHYSICIAN DID NOT PRE-DILATE THE LESION. IT WAS REPORTED THAT AS THE RACER WAS BEING ADVANCED, THE RACER STENT DISLODGED PRIOR TO MAKING THE TURN TO CROSS THE LESION. IT WAS REPORTED THAT THE DISLODGED STENT WAS CONTAINED ON THE GUIDE WIRE AND LOWERED ON THE WIRE TO THE ILIAC WHERE IT WAS CRUSHED USING A 7MM X 30 MM STENT BY ANOTHER MFR. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RACER BILIARY STENT SYSTEM FGE MEDTRONIC CARDIOVASCULAR NA 0000399492

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention