BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS ENDOVASCULAR STENT GRAFT

    MDR report key: 9957783 · Received April 14, 2020

    Report

    Report Number
    2020394-2020-02658
    Event Type
    Malfunction
    Date Received
    April 14, 2020
    Report Date
    April 14, 2020
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    PFV
    UDI-DI
    04049519008677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM1212 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A FRACTURE AND DEPLOYMENT ISSUES. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT IS A (B)(6) YEAR OLD MALE WEIGHING (B)(6) LBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423125 FLUENCY PLUS ENDOVASCULAR STENT GRAFT ENDOVASCULAR STENT GRAFT PFV BARD PERIPHERAL VASCULAR, INC. FEM12120 ANBW0124 04049519008677

    Patients

    Seq Age Sex Outcome Treatment
    1