BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1111617 · Received August 13, 2008

    Report

    Report Number
    9710478-2008-00093
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 23, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PREMATURE, PARTIAL DEPLOYMENT. TIME OF MALFUNCTION: DURING DEVICE PREPARATION. SYMPTOMS/AE: NA. IT WAS REPORTED THAT DURING A STENTING PROCEDURE IN THE POSTERIOR TIBIAL ARTERY, THE XPERT STENT DELIVERY SYSTEM WAS NOTICED TO HAVE PARTIALLY DEPLOYED WHEN IT WAS BACKLOADED ON THE GUIDEWIRE. THIS OCCURRED OUTSIDE OF THE BODY. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT 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 521054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA