BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS ENDOVASCULAR STENT GRAFT

    MDR report key: 4110642 · Received September 16, 2014

    Report

    Report Number
    9681442-2014-00123
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    PFV
    PMA / PMN Number
    P130029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER HAS BEEN PROVIDED. THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT JUMPED PROXIMALLY DURING DEPLOYMENT. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. THE STENT REMAINS IMPLANTED; NO FURTHER TREATMENT WAS PROVIDED. THERE WERE NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572020 FLUENCY PLUS ENDOVASCULAR STENT GRAFT ENDOVASCULAR STENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANYD3792

    Patients

    Seq Age Sex Outcome Treatment
    1