BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.25 X 12MM CORONARY STENT

    MDR report key: 2233211 · Received August 26, 2011

    Report

    Report Number
    2233211
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 26, 2011
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO CORONARY STENTS WERE PLACED IN THE PATIENT. DURING PLACEMENT OF THIRD STENT TO THE OSTIUM OF RIGHT CORONARY ARTERY (RCA), THE BALLOON "WATERMELONED" BACK INTO GUIDE WHILE THE BALLOON WAS INFLATED. THIS CAUSED THE STENT TO COME OFF THE BALLOON AND BECOME LODGED IN THE GUIDE. THE ENTIRE SYSTEM WAS REMOVED THROUGH THE SHEATH. IT WAS THOUGHT THAT THE STENT WAS IN THE GUIDE, BUT IT WAS NOT FOUND. UPON FLOUROSCOPY OF THE RIGHT LEG, THE STENT WAS VISUALIZED IN THE RIGHT LEG PROFINDA. THE DECISION WAS MADE TO LEAVE THE STENT ALONE.====================== MANUFACTURER RESPONSE FOR CORONARY STENT, 2.25 X 12MM CORONARY STENT (PER SITE REPORTER)======================NO COMMENTS WERE MADE TO RISK MANAGEMENT OR CATHETERIZATION LAB PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.25 X 12MM CORONARY STENT CORONARY STENT MAF ABBOTT VASCULAR * 1030141

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR CARDIAC DRUGS