BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS ENDOVASCULAR STENT GRAFT

    MDR report key: 9957286 · Received April 14, 2020

    Report

    Report Number
    2020394-2020-02647
    Event Type
    Malfunction
    Date Received
    April 14, 2020
    Report Date
    April 14, 2020
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    PFV
    UDI-DI
    04049519008707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND A LOT HISTORY REVIEW WAS PERFORMED. THE SAMPLE WAS RETURNED FOR EVALUATION. THE INVESTIGATION IS CONFIRMED FOR THE ALLEGED DEPLOYMENT AND MISFIRE ISSUES. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE WAS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF REPORTED INFORMATION INDICATES THAT MODEL FEM14080, ENDOVASCULAR STENT GRAFT, ALLEGEDLY EXPERIENCED MISFIRE AND FAILURE TO DEPLOY. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423432 FLUENCY PLUS ENDOVASCULAR STENT GRAFT ENDOVASCULAR STENT GRAFT PFV BARD PERIPHERAL VASCULAR, INC. FEM14080 ANDV3183 04049519008707

    Patients

    Seq Age Sex Outcome Treatment
    1