BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ ¿EVERFLEX¿ SELF EXPANDING PERIPHERAL STENT SYSTEM

    MDR report key: 2982710 · Received February 28, 2013

    Report

    Report Number
    2183870-2013-00057
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 11, 2013
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER IS UNAVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    POPLITEAL STICK, PERCUTANEOUS STENTING OF SFA/POP. PHYSICIAN REPORTS THE PROTEGE EVERFLEX STENT WAS JAMMED UPON DEPLOYMENT. THEY STRUGGLED INITIALLY GETTING THE STENT TO COME OUT, IT FINALLY DEPLOYED BUNCHY AND ELONGATED AS IT CAME OUT OF THE CATHETER. FOUR ADDITIONAL STENTS WERE DEPLOYED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88158 PROTÉGÉ ¿EVERFLEX¿ SELF EXPANDING PERIPHERAL STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. PRB35-07-150-120 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention