BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS

    MDR report key: 1133784 · Received August 15, 2008

    Report

    Report Number
    1133784
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 14, 2008
    Report Date
    August 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO CROSS THROUGH A STENT ALREADY IN PLACE IN CORONARY VESSEL, A 2.5X28 PROMUS STENT SNAGGED ON PROXIMAL PORTION OF THE STENT WHICH WAS IN PLACE. UPON REMOVAL FROM THE BODY, THE STENTS STRUTS WERE NOTED TO BE RAISED FROM THE BALLOON DISTAL PORTION. THE PHYSICIAN ADVANCED AND POST-DILATED THE FIRST STENT AND THEN WAS ABLE TO PLACE ANOTHER TYPE OF STENT IN THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS STENT, CORONARY, DRUG ELUTING MAF BOSTON SCIENTIFIC * 8022761

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR