BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1111619 · Received August 13, 2008

    Report

    Report Number
    9710478-2008-00095
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ABBOTT VASCULAR SWITZERLAND
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PREMATURE, PARTIAL DEPLOYMENT. TIME OF MALFUNCTION: DURING UNPACKAGING. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING UNPACKAGING OF THE DEVICE, THE XPERT STENT WAS FOUND TO BE PARTIALLY DEPLOYED. REPORTEDLY, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM FGE ABBOTT VASCULAR SWITZERLAND NA 432449

    Patients

    Seq Age Sex Outcome Treatment
    1