BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILLIARY STENT SYSTEM

    MDR report key: 1011342 · Received March 6, 2008

    Report

    Report Number
    9710478-2008-00024
    Event Type
    Malfunction
    Date Received
    March 6, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 12, 2008
    Manufacturer
    ABBOTT VASCULAR- VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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, STENT DEPLOYMENT. TIME OF MALFUNCTION: DURING DEVICE PREPARATION. SYMPTOMS/AE: NA. IT WAS REPORTED THAT DURING DEVICE PREPARATION OF THE XPERT STENT DELIVERY SYSTEM, THE STENT FULLY DEPLOYED OUTSIDE THE PT ANATOMY. REPORTEDLY, THERE WAS NO PT INVOLVEMENT. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING TRANSHEPATIC BILLIARY STENT SYSTEM FGE ABBOTT VASCULAR- VASCULAR SOLUTIONS NA 481937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA