BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    MDR report key: 1911730 · Received November 23, 2010

    Report

    Report Number
    2183870-2010-00185
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 15, 2010
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    THIS PROCEDURE WAS PERFORMED ON THE SFA IN (B)(6) . DURING A PROCEDURE ON THE SFA, COMPLETE STENT DEPLOYMENT WAS NOT POSSIBLE. THE OUTER SHEATH OF THE CATHETER DID NOT MOVE AFTER THE FIRST STENT STRUTS WERE DEPLOYED. A SECOND STENT WAS DEPLOYED TO SECURE THE PORTION OF THE PROTEGE EVERFLEX THAT WAS LEFT IN THE PT. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT FGE EV3 INC. PRP35-06-150-120 8506324

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention