BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1161517 · Received September 15, 2008

    Report

    Report Number
    9710478-2008-00110
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 4, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. THE SECOND XPERT STENT (LOT 451477) IS BEING FILED ON A SEPARATE MEDWATCH.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PREMATURE, PARTIAL DEPLOYMENT. TIME OF MALFUNCTION: IN THE PACKAGE. SYMPTOMS/AE: NA. IT WAS REPORTED THAT THE XPERT STENT WAS FOUND PREMATURELY, PARTIALLY DEPLOYED IN THE PACKAGE. THE DEVICE WAS NOT USED AND THERE WAS NO PT INVOLVEMENT. A SECOND XPERT STENT PREMATURELY, FULLY DEPLOYED WHEN AN ATTEMPT WAS MADE TO LOAD IT ON THE GUIDE WIRE. THIS OCCURRED OUTSIDE OF THE BODY, AND THERE WAS NO PT INVOLVEMENT. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM FGE ABBOTT VASCULAR SWITZERLAND NA 462525

    Patients

    Seq Age Sex Outcome Treatment
    1 NA