BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 3202191 · Received June 28, 2013

    Report

    Report Number
    3005325609-2013-00021
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. THE STENT WAS BEING DEPLOYED WITHIN A PREVIOUSLY DEPLOYED STENT . THE PHYSICIAN HAD DIFFICULTY VISUALIZING THE REMAINING LENGTH OF THE CONSTRAINED STENT IN THE DELIVERY SYSTEM. THE PHYSICIAN DID NOT DEPLOY THE ENTIRE STENT BEFORE REMOVING THE CATHETER; THEREFORE, THE PROXIMAL END OF THE STENT WAS TRAPPED INSIDE THE DELIVERY SYSTEM BY THE TIP. AS THE DELIVERY SYSTEM WAS WITHDRAWN PROXIMALLY FOR REMOVAL, THE TIP DETACHED WHEN THE WITHDRAWAL FORCES OF MOVING THE PARTIALLY DEPLOYED STENT THROUGH THE VESSEL AND INTRODUCER SHEATH EXCEEDED THE TENSILE STRENGTH OF THE TIP LUMEN. THE DETACHED TIP REMAINED ON THE GUIDEWIRE AND WAS REMOVED. THROUGH TESTING, SUFFICIENT VISIBILITY OF THE STENT AS BEEN VERIFIED. THE PHYSICIAN MAY NOT HAVE CHOSEN A HIGH ENOUGH MAGNIFICATION ON THE FLUOROSCOPY MACHINE. THE CAUSE OF THE EVENT HAS BEEN DISCUSSED WITH THE PHYSICIAN. A CAPA FOR THESE TYPES OF EVENTS HAS BEEN OPENED.

    Description of Event or Problem · 1

    FOLLOWING STENT DEPLOYMENT, UPON REMOVAL OF THE CATHETER IT WAS NOTED THAT THE TIP OF THE CATHETER WAS ON THE GUIDEWIRE WHEN REMOVED. THE PHYSICIAN DID NOT DEPLOY THE ENTIRE STENT BEFORE REMOVING THE CATHETER; THEREFORE, THE PROXIMAL END OF THE STENT WAS TRAPPED INSIDE THE DELIVERY SYSTEM. THERE WAS NO INTERVENTION AND NO EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295066 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-05-120-120-6F 02083061

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR