BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK EXL PLAQUE EXCISION SYSTEM

    MDR report key: 1840874 · Received September 16, 2010

    Report

    Report Number
    2183870-2010-00151
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 19, 2010
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS AVAILABLE.

    Description of Event or Problem · 1

    THIS PROCEDURE IS PART OF THE DEFINITIVE LE TRIAL. THE RIGHT POSTERIOR TIBIAL ARTERY WAS PERFORATED WHILE PERFORMING ATHERECTOMY WITH THE SILVER-HAWK. DEBRIS EMBOLIZED DOWN STREAM FROM THE TARGET LESION. THE PERFORATION WAS RESOLVED WITH ANGIOPLASTY. NO INJURY TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK EXL PLAQUE EXCISION SYSTEM MCW EV3 INC. P4044 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention