BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC STENT SYSTEM

    MDR report key: 1081932 · Received July 23, 2008

    Report

    Report Number
    9710478-2008-00083
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 30, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED COMPLETE. THE STENT WAS PARTLY DEPLOYED BY 1.5 STRUT ROWS. THE STENT WAS FULLY DEPLOYABLE AND DID NOT SHOW ANY ABNORMALITIES. THE TUOHY BORST VALVE WAS CLOSED AND THE DEVICE WAS FLUSHABLE. THE GUIDE WIRE WAS INSERTED FROM THE DISTAL AS WELL AS FROM THE PROXIMAL SIDE OF THE DEVICE WITHOUT ANY ABNORMALITIES. A ROOT CAUSE FOR THE PREMATURE DEPLOYMENT OF THE STENT COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED 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 MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A STENTING PROCEDURE IN THE SUBHEPATIC VEIN, USING A TRANSJUGULAR APPROACH, THE XPERT STENT PREMATURELY, PARTIALLY DEPLOYED PROXIMAL TO THE LESION. THE STENT AND DELIVERY SYSTEM WERE REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT. 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 521046

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COOK CHECK-FLOW SHEATH| CORDIS AMPLATZ 180 CM GUIDE CATHETER