BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK® PLAQUE EXCISION SYSTEM

    MDR report key: 2091586 · Received May 17, 2011

    Report

    Report Number
    2183870-2011-00096
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    July 14, 2010
    Report Date
    April 18, 2011
    Manufacturer
    EV3 INC
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS PROCEDURE IS PART OF THE DEFINITIVE LE STUDY: A SMALL PERFORATION OF THE ARTERY DURING THE PROCEDURE WAS NOTICED AND FIXED BY PLACING A COVERED STENT IN THE SFA AT RULER MARKER 24CM TO 29CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK® PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC LX-M 8617847

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention