BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ ®EVERFLEX¿ SELF EXPANDING NITINOL STENT

    MDR report key: 2162476 · Received July 14, 2011

    Report

    Report Number
    2183870-2011-00137
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 14, 2011
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON THE SFA, AFTER THE PHYSICIAN DEPLOYED THE PROTEGE EVERFLEX, THE TIP OF STENT DEPLOYMENT SYSTEM DISLODGED REQUIRING A SNARE TO CAPTURE THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTÉGÉ ®EVERFLEX¿ SELF EXPANDING NITINOL STENT CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. PRB35-07-080-120 7822904

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention