BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUENCY PLUS ENDOVASCULAR SENT GRAFT

    MDR report key: 4567341 · Received March 2, 2015

    Report

    Report Number
    9681442-2015-00015
    Event Type
    Injury
    Date Received
    March 2, 2015
    Date of Event
    January 28, 2015
    Report Date
    February 2, 2015
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    PFV
    PMA / PMN Number
    P130029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 STENT GRAFT WHICH WAS IMPLANTED IN (B)(6) 2014 IN THE RIGHT SUBCLAVIAN ARTERY WAS FOUND TO BE BLOCKED. THEN A BARE STENT WAS DEPLOYED, OVERLAPPING AND EXTENDING THE STENTED AREA PROXIMALLY. NO PT INJURY WAS REPORTED. THIS IS THE SAME PT AS REPORTED IN MEDWATCH REPORT # 961442-2015-00013 AND 961442-2015-00014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143073 FLUENCY PLUS ENDOVASCULAR SENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANYE2488

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention