BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1032942 · Received April 23, 2008

    Report

    Report Number
    9710478-2008-00044
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 27, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PREMATURELY DEPLOYED STENT. TIME OF MALFUNCTION: WHILE BACKLOADING ONTO THE GUIDEWIRE. SYMPTOMS/AE: NA. IT WAS REPORTED THAT WHILE THE XPERT STENT WAS BEING BACKLOADED ONTO THE GUIDEWIRE, THE STENT BECAME PARTIALLY DEPLOYED BY ONE STRUT ROW. REPORTEDLY, THERE WAS NO PT INVOLVEMENT. THOUGH REQUESTED, NO ADDITIONAL INFO WAS 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1