BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V12 COVERED STENT

    MDR report key: 3080911 · Received April 24, 2013

    Report

    Report Number
    1219977-2013-00047
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ATRIUM MEDICLA CORP
    Product Code
    JCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IN THE PROCESS OF EVALUATION.

    Description of Event or Problem · 1

    IBD CASE USING 10 X 59MM STENT TRACKED TIGHTLY FORWARD THROUGH THE 7FR INTRODUCER CATHETER. THE BALLOON WAS UNABLE TO BE FULLY DEFLATED POST DEPLOYMENT AND HAD TO REMOVE SHEATH AND BALLOON TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178234 V12 COVERED STENT PTFE COVERED STENT JCT ATRIUM MEDICLA CORP 85336 10617047

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK ROSE GUIDEWIRE: .035, 260CM| COOK FLEXOR INTRODUCER SHEATH: 7FR, 55CM