BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO BALLOON EXAPNDABLE BILIARY STENT

    MDR report key: 2220529 · Received July 18, 2011

    Report

    Report Number
    2020394-2011-00162
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    FGE
    PMA / PMN Number
    K052132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THE STENT REMAINS IMPLANTED AND THE DELIVERY SYSTEM WAS DISCARDED BY THE USER FACILITY. THEREFORE, A SAMPLE EVAL COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT PREMATURELY DETACHED FROM THE CATHETER AT THE EXTERNAL ILIAC ARTERY, WHERE IT WAS THEN EXPANDED AND IMPLANTED. THE INTENDED TREATMENT SITE WAS THE SUPERFICIAL FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALEO BALLOON EXAPNDABLE BILIARY STENT FGE BARD PERIPHERAL VASCULAR, INC. GFUG1557

    Patients

    Seq Age Sex Outcome Treatment
    1