BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILLIARY STENT SYSTEM

    MDR report key: 1051562 · Received May 19, 2008

    Report

    Report Number
    9710478-2008-00054
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 25, 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
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OFF LABEL USE. THE DEVICE WAS REC'D. INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULT TO POSITION, PREMATURE, PARTIAL STENT DEPLOYMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT AS THE XPERT STENT DELIVERY SYS (SDS) WAS BEING ADVANCED TO THE TARGET LESION IN THE DISTAL SUPERFICIAL FEMORAL POPLITEAL ARTERIES VIA AN IPSILATERAL APPROACH, OVER A STEELCORE GUIDEWIRE, THE STENT BECAME STUCK ON THE WIRE AND PREMATURELY PARTIALLY DEPLOYED PROXIMAL TO THE LESION. THE STENT, SDS, WIRE AND SHEATH WERE REMOVED AS A SINGLE UNIT. AFTER REMOVAL A KINK WAS NOTICED IN THE WIRE. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING TRANSHEPATIC BILLIARY STENT SYSTEM FGE ABBOTT VASCULAR SWITZERLAND NA 432487

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STEELCORE .018 GUIDE WIRE