BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V12 COVERED STETN

    MDR report key: 3080930 · Received April 24, 2013

    Report

    Report Number
    1219977-2013-00048
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ATRIUM MEDICAL CORP
    Product Code
    JCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IN PROCESS OF EVALUATION.

    Description of Event or Problem · 1

    IBD CASE UNABLE TO TRACK 10 X 59MM STENT FORWARD THROUGH A 7FR SHEATH. HAD TO EXCHANGE FOR A STIFF WIRE AND TRACK THE STENT OVER THE ARCH THROUGH THE 12FR SHEATH AND BAREBACK INTO THE INTERNAL ILIAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176758 V12 COVERED STETN PTFE COVERED STENT JCT ATRIUM MEDICAL CORP 85361 10861101

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK FLEXOR INTRODUCER SHEATH: 7FR| ROSEN GUIDEWIRE: .035, 260