BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1161519 · Received September 15, 2008

    Report

    Report Number
    9710478-2008-00112
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 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
    PA, 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 DEPLOYMENT. TIME OF MALFUNCTION: DURING DEVICE PREPARATION. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A STENTING PROCEDURE IN AN UNSPECIFIED SITE, THE XPERT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND STENT DEPLOYMENT WAS ATTEMPTED; HOWEVER, IT WAS OBSERVED THAT THE STENT WAS NOT ON THE SDS. THE SDS WAS REMOVED AND THE STENT WAS FOUND IN THE DEVICE PACKAGING. THERE WAS NO ADVERSE PT EFFECT. A SECOND XPERT SDS WAS UNPACKAGED. THE END OF THIS STENT WAS "CRIMPED" AND THE DEVICE WAS NOT USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A THIRD XPERT STENT. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED, NO ADD'L 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 524060

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK