BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS LIFESTENT SDS BILIARY STENT SYSTEM

    MDR report key: 594788 · Received April 21, 2005

    Report

    Report Number
    6000002-2005-00213
    Event Type
    Injury
    Date Received
    April 21, 2005
    Date of Event
    March 23, 2005
    Report Date
    March 23, 2005
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN ACCESS TO LEFT SUPERICIAL FEMORAL ARTERY WAS ATTEMPTED FROM RIGHT BRACHIAL SITE, STENT WOULD NOT DELIVER. WHEN REMOVAL OF STENT WAS ATTEMPTED, IT BECAME STUCK AT SHEATH. SHEATH WAS REMOVED AND STENT REMAINED IN BRACHIAL ARTERY AND CAUSED BLEEDING. PATIENT UNDERWENT SURGERY TO REMOVE STENT. THIS EVENT WAS AN OFF-LABEL USE OF THE DEVICE AS DEVICE IS INDICATED FOR USE IN THE BILIARY TREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS LIFESTENT SDS BILIARY STENT SYSTEM BILIARY STENT FGE EDWARDS LIFESCIENCES SD26826D 4E0837

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention