BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILLIARY STENT SYSTEM

    MDR report key: 1022384 · Received March 26, 2008

    Report

    Report Number
    9710478-2008-00035
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN REC'D.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PREMATURE, PARTIAL DEPLOYMENT. TIME OF MALFUNCTION: DURING PREPARATION. SYMPTOMS/AE: NA. IT WAS REPORTED THAT DURING DEVICE PREPARATION THE XPERT STENT WAS FOUND PREMATURELY, PARTIALLY DEPLOYED BY 2 STRUT ROWS. REPORTEDLY THERE WAS NO PT INVOLVEMENT. THOUGH REQUESTED, NO ADDITIONAL 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 NA 494836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA