BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILLIARY STENT SYSTEM

    MDR report key: 1032177 · Received April 21, 2008

    Report

    Report Number
    9710478-2008-00043
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 28, 2008
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT YET COMPLETED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PREMATURE, PARTIAL STENT DEPLOYMENT. TIME OF DEVICE MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT WHILE ADVANCING THE STENT IN THE SUPERFICIAL FEMORAL ARTERY, THE STENT PREMATURELY, PARTIALLY DEPLOYED. THE DEVICE WAS REMOVED WITHOUT INCIDENT. AFTER REMOVAL, IT WAS NOTICED THAT THE STENT STRUTS WERE BENT. A SECOND XPERT STENT WAS SUCCESSFULLY DEPLOYED IN THE TARGET LESION. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING TRANSHEPATIC BILLIARY STENT SYSTEM FGE ABBOTT VASCULAR NA 50661

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR