BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING STENT SYSTEM

    MDR report key: 1213768 · Received October 22, 2008

    Report

    Report Number
    9710478-2008-00144
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 30, 2008
    Report Date
    September 30, 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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PREMATURE DEPLOYMENT. TIME OF MALFUNCTION: DURING UNPACKAGING. SYMPTOMS/AE: NA. IT WAS REPORTED THAT DURING UNPACKAGING, IT WAS NOTICED THAT THE XPERT STENT WAS PREMATURELY, PARTIALLY DEPLOYED. THERE WAS NO PT INVOLVEMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER XPERT STENT. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING STENT SYSTEM FGE ABBOTT VASCULAR SWITZERLAND NA 445695

    Patients

    Seq Age Sex Outcome Treatment
    1 NA