BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS2 OTW CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1030618 · Received April 16, 2008

    Report

    Report Number
    2134265-2008-01117
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Report Date
    March 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P020009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE TARGET LESION WAS IN THE LEFT CIRCUMFLEX CORONARY ARTERY. THE PHYSICIAN HAD SELECTED A 2.5X12 MM EXPRESS2 BARE METAL STENT (BMS) AND INTRODUCED THE DEVICE INTO AN UNK TYPE GUIDE CATHETER. THE PHYSICIAN WAS UNABLE TO CANNULATE THE OSTIUM WITH THE GUIDE AND REMOVED "EVERYTHING". IT WAS NOTICED THAT THE STENT STRUT OF THE EXPRESS2 BMS APPEARED LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5X12 MM EXPRESS2 BMS. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 OTW CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC NA 9326859

    Patients

    Seq Age Sex Outcome Treatment
    1