BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER WIRE ADVANCE

    MDR report key: 2100908 · Received May 18, 2011

    Report

    Report Number
    MW5020664
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 18, 2011
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN ANGIOPLASTY WIRE (VIPER WIRE) HAD BROKEN OFF LEAVING THE VERY TIP OF IT AND LODGED AT THE DISTAL END OF THE TREATED SEGMENT IN THE POPLITEAL. THIS WAS A VERY SMALL PIECE OF WIRE, BUT IT WAS STILL WITHIN THE LUMEN OF THE VESSEL. IT WAS SUBSEQUENTLY TREATED BY REMOVING THE VIPER WIRE AND CSI DEVICE, REPLACING IT WITH A PT GRAPHIX WIRE DOWN THE PERONEAL AND THEN A 4 MM X 9 MM LONG CORONARY STENT, BARE METAL, WAS BROUGHT DOWN AND USED TO TREAT THE AREA OF THE WIRE. WITH THIS HAVING BEEN ACCOMPLISHED SUBSEQUENT ANGIOGRAPHY SHOWED WIDE PATENCY, NO SIGNIFICANT RESIDUAL STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER WIRE ADVANCE VIPERWIRE MCW CARDIOVASCULAR SYSTEMS, INC VPR-GW-14 43593

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization