BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS

    MDR report key: 2771327 · Received September 28, 2012

    Report

    Report Number
    2771327
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    June 20, 2012
    Report Date
    September 28, 2012
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC CATHETERIZATION, A PROMUS CORONARY STENT WAS ADVANCED BY THE DOCTOR TO THE RIGHT CORONARY ARTERY (RCA). AS THE STENT WAS ADVANCED, THE STENT FELL OFF OF THE BALLOON AND WAS DEPLOYED IN THE AORTA NOT THE IN THE RCA. THE DOCTOR THEN TOOK A SNARE UP THE AORTA AND REMOVED THE STENT. HE THEN CHOSE A DIFFERENT CORONARY STENT WHICH WAS SUCCESSFULLY DEPLOYED IN THE RCA. THE PATIENT WAS AWARE OF THE SITUATION AND THE PATIENT WAS STABLE DURING THE ENTIRE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC * 1081861

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR