BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT VALEO BILIARY STENT

    MDR report key: 1570873 · Received December 29, 2009

    Report

    Report Number
    2020394-2009-00491
    Event Type
    Malfunction
    Date Received
    December 29, 2009
    Date of Event
    November 27, 2009
    Report Date
    December 3, 2009
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER. THE STENT REMAINS IMPLANTED AND THE DELIVERY SYSTEM WAS DISCARDED BY THE USER FACILITY. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE U.S 510(K) -K052132.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CROSSING A STENOSIS BEFORE BALLOON EXPANSION OF THE STENT, THE STENT DETACHED FROM THE BALLOON AND CATHETER. THE STENT WAS DEPLOYED, UNOPENED, IN THE SUBCLAVIAN ARTERY. THE CATHETERIZATION OF THE SUBCLAVIAN ARTERY COULD NOT BE PERFORMED. THERE WAS NO ADVERSE CLINICAL CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT VALEO BILIARY STENT FGE BARD PERIPHERAL VASCULAR, INC. GFTJ1519

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR