BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS ENDOVASCULAR STENT GRAFT

    MDR report key: 9955680 · Received April 13, 2020

    Report

    Report Number
    2020394-2020-02646
    Event Type
    Malfunction
    Date Received
    April 13, 2020
    Report Date
    April 13, 2020
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    PFV
    UDI-DI
    04049519008622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER IDENTIFIED HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT PRODUCTS THAT ARE CLEARED IN THE US. THE PRODUCT CLASSIFICATION CODE FOR THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT PRODUCT IS IDENTIFIED. THE LOT NUMBER FOR THE MALFUNCTION WAS PROVIDED AND A LOT HISTORY REVIEW WAS PERFORMED. THE DEVICE HAS BEEN RETURNED FOR EVALUATION; THE EVALUATION CONFIRMED MISFIRE AND POSITIONING FAILURE. BASED UPON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM10120 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED MISFIRE AND POSITIONING FAILURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE 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
    415985 FLUENCY PLUS ENDOVASCULAR STENT GRAFT ENDOVASCULAR STENT GRAFT PFV BARD PERIPHERAL VASCULAR, INC. FEM10120 ANDQ2649 04049519008622

    Patients

    Seq Age Sex Outcome Treatment
    1