BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 3130202 · Received May 22, 2013

    Report

    Report Number
    3005325609-2013-00012
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 23, 2013
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED (NOT RETURNED FOR ANALYSIS). A LIMITED INVESTIGATION WAS PERFORMED AND PER THE INFO RECEIVED FROM THE PROCEDURE, THE LIKELY CAUSE OF THE EVENT WAS THAT THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED IN THAT THE USER INCORRECTLY DEPLOYED THE PROXIMAL END OF THE STENT INSIDE THE INTRODUCER SHEATH. THIS WILL CAUSE THE TIP ASSEMBLY TO BE CONSTRAINED RESULTING IN RESISTANCE WHILE PULLING IT BACK.

    Description of Event or Problem · 1

    THE STENT WAS NOT FULLY RELEASED FROM THE SHEATH AND IT WAS PULLED BACK INTO A PREVIOUSLY DEPLOYED STENT IN THE ILIAC. THE PHYSICIAN VIEWED THIS UNDER FLUOROSCOPY AND THEN RELEASED THE STENT. THE DELIVERY SYSTEM'S TIP WAS VIEWED ON THE GUIDEWIRE IN THE COMMON FEMORAL. A SNARE DEVICE WAS USED TO REMOVE IT. THERE WAS NO EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227300 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-06-040-120-6F 02026065

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR