BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK LS-M PLAQUE EXCISION SYSTEM

    MDR report key: 1923572 · Received December 3, 2010

    Report

    Report Number
    2183870-2010-00188
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 5, 2010
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    UPON REMOVAL OF THE SILVERHAWK LS-M DEVICE AFTER ATHERECTOMY OF THE SFA, TENSION WAS NOTED. THE PHYSICIAN TRIED TURNING THE DEVICE ON AND OFF TO MAKE SURE IT WAS COMPLETELY CLOSED. THE PHYSICIAN NOTICED THE DEVICE SEEMED TO BE ANGLING TOO MUCH AND ATTEMPTED TO REMOVE EVERYTHING. HOWEVER, THEY WERE UNABLE TO REMOVE ANYTHING AT THIS POINT. THE PATIENT WAS TAKEN TO SURGERY AND UPON COMPLETION OF A CUT DOWN, EVERYTHING WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK LS-M PLAQUE EXCISION SYSTEM MCW EV3 INC. P4052 8492255

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention SPIDERFX 5MM