BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1063633 · Received June 19, 2008

    Report

    Report Number
    9710478-2008-00069
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 26, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. DEVICE CODE (USED IN SUPERFICIAL FEMORAL ARTERY).

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULTY ADVANCING, PARTIAL PREMATURE DEPLOYMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE OF A DISTAL SUPERFICIAL FEMORAL ARTERY, THE XPERT STENT DELIVERY SYSTEM (SDS) COULD NOT BE ADVANCED THROUGH THE ANATOMY TO THE LESION. THE SDS WAS REMOVED FROM THE ANATOMY AND THE STENT WAS NOTICED TO BE PARTIALLY DEPLOYED. ANOTHER XPERT STENT WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO ADVERSE PT EFFECT. 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 427505

    Patients

    Seq Age Sex Outcome Treatment
    1