BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC STENT SYSTEM

    MDR report key: 1051564 · Received May 19, 2008

    Report

    Report Number
    9710478-2008-00055
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 20, 2008
    Report Date
    April 24, 2008
    Manufacturer
    ABBOTT VASCULAR BERINGEN
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN REC'D.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PARTIAL STENT DEPLOYMENT. TIME OF MALFUNCTION: DURING DEVICE PREPARATION. SYMPTOMS/AE: NA. IT WAS REPORTED THAT DURING DEVICE PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE XPERT STENT WAS ALREADY PARTIALLY DEPLOYED. REPORTEDLY, THERE WAS NO PT INVOLVEMENT. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING TRANSHEPATIC STENT SYSTEM FGE ABBOTT VASCULAR BERINGEN NA 500861

    Patients

    Seq Age Sex Outcome Treatment
    1 NA