BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ ®EVERFLEX¿ SELF EXPANDING NITINOL STENT

    MDR report key: 1962140 · Received January 17, 2011

    Report

    Report Number
    2183870-2011-00007
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 21, 2010
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED ON THE RIGHT SFA VIA THE LEFT FEMORAL ARTERY ON (B)(6), 2008. DURING A RECENT ANGIOGRAM ON (B)(6) 2010, THE PHYSICIAN NOTED THAT THE STENT WAS FRACTURED. NO INTERVENTIONS WERE PERFORMED AT THE FOLLOW-UP PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTÉGÉ ®EVERFLEX¿ SELF EXPANDING NITINOL STENT CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. PRB35-06-150-120 5604210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other