BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICAST COVERED STENT

    MDR report key: 3060631 · Received April 5, 2013

    Report

    Report Number
    1219977-2013-00026
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ATRIUM MEDICAL CORP
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE IS CURRENTLY UNDER EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THE DEVICE WAS FOUND TO HAVE MET ALL SPECIFICATIONS WITHOUT ANY DEVIATIONS.

    Description of Event or Problem · 1

    GORIN ACCESS WAS ESTABLISHED FOR A POSSIBLE INTERVENTION OF THE PTS SMA. ANGIOGRAPHY SHOWED STENOSIS, THE DECISION WAS MADE TO DEPLOY A 7X22 ICAST IN THE SMA. THE .035 WIRE ACCESS WAS OBTAINED AND A 7FR 45CM SHEATH WAS PLACED INTO THE SMA FOR STENT DELIVERY. PHYSICIANS NOTED THAT IT WAS DIFFICULT TO PASS THE STENT OVER THE WIRE AND NOTICED BEFORE THE BEND IN THE SHEATH THAT THE STENT WAS PARTIALLY DISLODGED. REMOVED THE SHEATH AND STENT, REPLACE WITH NEW SHEATH, USED THE SAME WIRE AND SUCCESSFULLY ADVANCED AND DEPLOYED A 6X22 ICAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139975 ICAST COVERED STENT JCT ATRIUM MEDICAL CORP 85455 10834235

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO GLIDEWIRE ADVANTAGE - .035 180 CM| COOK RAABE - 7FR 45 CM