BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC STENT SYSTEM

    MDR report key: 1160017 · Received September 12, 2008

    Report

    Report Number
    9710478-2008-00108
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 21, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITY WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PREMATURE, PARTIAL DEPLOYMENT. TIME OF DEVICE MALFUNCTION: DURING INSERTION INTO SHEATH. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT THE XPERT STENT PREMATURELY, PARTIALLY DEPLOYED DURING ATTEMPTED INSERTION INTO THE SHEATH. THE DEVICE WAS REMOVED FROM THE WIRE AND WAS NOT USED. THIS OCCURRED OUTSIDE THE BODY AND THERE WAS NO PATIENT INVOLVEMENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING TRANSHEPATIC STENT SYSTEM FGE ABBOTT VASCULAR SWITZERLAND NA 416853

    Patients

    Seq Age Sex Outcome Treatment
    1 NA