BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK® PLAQUE EXCISION SYSTEM

    MDR report key: 2083512 · Received May 10, 2011

    Report

    Report Number
    2183870-2011-00090
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    October 6, 2009
    Report Date
    April 11, 2011
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS 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 (B)(6) STUDY: A SILVERHAWK LS-C DEVICE WAS BROUGHT DOWN AND MULTIPLE PASSES WERE MADE . THERE WAS IMPROVED FLOW AT THE END OF THIS: HOWEVER, THERE WAS FLOW-LIMITING DISSECTION AS WELL AS LOW RESIDUAL CRITICAL STENOSIS. THUS, A 5 X 150 BALLOON WAS BROUGHT DOWN AND USED TO ANGIOPLASTY THESE LESIONS. UPON COMPLETION OF THIS, THERE WAS NOTED TO BE A BRISK FLOW TO THE SUPERFICIAL FEMORAL ARTERY INTO THE POPLITEAL ARTERY WITH FLOW INTO THE ANTERIOR TIBIAL ARTERY. THERE WAS NO EVIDENCE OF ANY DISTAL EMBOLIZATION. THE SHEATH WAS THEN WITHDRAWN TO THE AORTIC BIFURCATION. ANGIOGRARN WAS PERFORMED DEMONSTRATING NO TRAUMA TO THE AORTIC BIFURCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK® PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. LS-C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention BALKIN SHEATH