BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC PROMUS PREMIER 2.25 MM X 32 MM

    MDR report key: 4181873 · Received July 29, 2014

    Report

    Report Number
    4181873
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 9, 2014
    Report Date
    July 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LESION WAS CROSSED WITH A BMW WIRE, BUT COULD NOT PRIMARY STENT IT. WE HAD BUDDY WIRE WITH A WHISPER WIRE, AND STILL COULD NOT PRIMARY STENT IT. WE DILATED THIS WITH A 2 MM BALLOON. WE THEN STENTED THIS VESSEL, REMOVED THE BALLOON. ANGIOGRAPHY WAS PERFORMED REVEALING A STENOSIS DISTALLY. THIS APPEARED TO BE A NOT FULLY DEPLOYED STENT, BUT THERE IS AN AREA THAT WE WERE CONCERNED THE STENT HAD ACCORDIONED. WE COULD NOT RECROSS WITH THE STENT BALLOON. TRIED CROSSING WITH A NONCOMPLIANT 2.25 MM BALLOON. WE WERE ABLE TO DILATE THE AREA PROXIMAL TO THIS DISTAL AREA, WHICH HAD THE ACCORDION AREA IN IT. WE LOST WIRE POSITION AND WERE UNABLE TO REWIRE IT. FINALLY WE USED A PILOT WIRE. WE WERE ABLE TO WIRE DISTALLY, BUT THE WIRE DID NOT APPEAR TO BE CLEARLY IN THE LUMEN. PATIENT WAS SENT TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441475 BOSTON SCIENTIFIC PROMUS PREMIER 2.25 MM X 32 MM CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC CORP. 39528-3222 16737449

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR