BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOS ELEMENT PLUS MONORAIL DRUG ELUTING STENT

    MDR report key: 2931748 · Received January 16, 2013

    Report

    Report Number
    2931748
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US

    Narratives

    Description of Event or Problem · 1

    THE CARDIOLOGIST WAS ATTEMPTING TO CROSS A LESION IN THE DISTAL CIRCUMFLEX. THE STENT WOULD NOT CROSS THE LESION. WHEN ATTEMPTING TO PULL IT BACK INTO THE GUIDE IT WOULD NOT GO. FLUORO SHOWED THAT THE PROXIMAL STENT STRUTS WERE FLARED AND STICKING OUT FROM THE DELIVERY BALLOON. THE STENT, DELIVERY BALLOON, INTERVENTIONAL WIRE, AND GUIDE WIRE WERE REMOVED AS ONE UNIT THROUGH THE GROIN SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23522 PROMOS ELEMENT PLUS MONORAIL DRUG ELUTING STENT CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC * 15664564

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR