BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1172512 · Received September 19, 2008

    Report

    Report Number
    2134265-2008-02746
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE CALCIFIED AND SEVERLY TORTOUS DISTAL RIGHT CORONARY ARTERY (RCA). PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED ON THE LESION WITH A 2.5MM NON-BSC BALLOON CATHETER. THEN THE PHYSICIAN BEGAN ADVANCING THE 2.50X24MM TAXUS EXPRESS2 DRUG ELUTING STENT TO LESION AND FELT RESISTANCE IN THE PROXIMAL RCA. THE DEVICE WAS REMOVED FROM THE PATIENT AND A RAISED STENT STRUT WAS OBSERVED. THERE WERE NO PATIENT COMPLICATIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 2.50X24MM TAXUS EXPRESS2 DRUG ELUTING STENT. PATIENT STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.50X24MM 9659839

    Patients

    Seq Age Sex Outcome Treatment
    1 6F ACCESS JR4SH GUIDE CATHETER| 1.25MM SPEEDER| 2.5MM LEGEND BALLOON CATHETERS| RUNTHROUGH FLOPPY GUIDEWIRE