BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESTENT NT SELF EXPANDING BILIARY STENT AND DELIVERY SYS

    MDR report key: 851336 · Received May 11, 2007

    Report

    Report Number
    6000002-2007-00378
    Event Type
    Other
    Date Received
    May 11, 2007
    Date of Event
    June 22, 2005
    Report Date
    June 22, 2005
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DILATOR FOUND THAT THE TIP OF THE DILATOR HAS A SQUARE EDGE WHICH MOST LIKELY GOT CAUGHT ON THE STENT. IN AN EFFORT TO PREVENT THE RECURRENCE OF THIS ISSUE, WE HAVE MADE AN ENHANCEMENT TO THIS PART WITH A CHAMBER AT THE PROXIMAL EDGE TO REDUCE THE LIKELIHOOD OF THE EDGE CATCHING AS ITS BEING WITHDRAWN FROM THE VASCULATURE. EVALUATION RESULTS FOUND THE PROXIMAL EDGE OF THE DILATOR TIP HAS A SQUARE EDGE DUE TO THE MANUAL CUTTING PROCESS. THIS CONDITION MOST LIKELY CAUSED IT TO CATCH ON THE STENT.

    Description of Event or Problem · 1

    REPORTEDLY, THE STENT WAS DEPLOYED WITHOUT ISSUES. WHEN THEY WENT TO PULL THE DEPLOYMENT SYS OUT, THE VERY TIP OF THE DEPLOYMENT SYS GOT CAUGHT ON THE STENT. THE DR. GENTLY ADVANCED BACK THRU THE STENT AND PULLED IT BACK OUT WITHOUT ANY PT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT NT SELF EXPANDING BILIARY STENT AND DELIVERY SYS BILIARY STENT FGE EDWARDS LIFESCIENCES NT358301D SE5B0138

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other