BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILLIARY STENT SYSTEM

    MDR report key: 1022400 · Received March 26, 2008

    Report

    Report Number
    9710478-2008-00036
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PREMATURE, PARTIAL DEPLOYMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN INTERVENTIONAL, ANTERIOR TIBIAL ARTERY PROCEDURE, THE XPERT SHEATH KINKED IN DIFFICULTY ADVANCING THE STENT DELIVERY SYSTEM (SDS). THE SDS WAS REMOVED WITHOUT DIFFICULTY. AFTER REMOVAL, IT WAS FOUND THAT THE STENT HAD PREMATURELY, PARTIALLY DEPLOYED. A NON-ABBOTT STENT AND TWO OTHER XPERT STENTS WERE SUCCESSFULLY IMPLANTED COMPLETING THE PROCEDURE. 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 386421

    Patients

    Seq Age Sex Outcome Treatment
    1 XPERT STENT (2)| CYPHER STENT DES STENT