BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1840673 · Received September 17, 2010

    Report

    Report Number
    9710478-2010-00116
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKAGING OF THE DEVICE, IT WAS NOTED THAT THE STENT WAS EXPOSED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM FGE ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 633214

    Patients

    Seq Age Sex Outcome Treatment
    1