BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC STENT SYSTEM

    MDR report key: 1111618 · Received August 13, 2008

    Report

    Report Number
    9710478-2008-00094
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 22, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED COMPLETE. THERE WAS A KINK IN THE METAL SHAFT. THE STENT WAS PARTLY DEPLOYED BY 7 STRUT ROWS. THE STENT WAS FULLY DEPLOYABLE AND DID NOT SHOW ANY ABNORMALITIES. THE TUOHY BORST VALVE WAS CLOSED AND THE DEVICE WAS FLUSHABLE. A 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 STENT DEPLOYMENT COULD NOT BE DETERMINED. NO EVIDENCE OF A MANUFACTURING ISSUE WAS DETECTED. 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 DEVICE PREPARATION. SYMPTOMS/AE: IT WAS REPORTED THAT DURING DEVICE PREPARATION WHEN THE STENT DELIVERY SYSTEM WAS BEING LOADED ON THE GUIDE WIRE, IT WAS NOTICED THAT THE STENT WAS PARTIALLY DEPLOYED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. 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 488939

    Patients

    Seq Age Sex Outcome Treatment
    1 NA