BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1030536 · Received April 17, 2008

    Report

    Report Number
    2134265-2008-01100
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE. THE DAMAGE WAS FOUND ON THE THIRD AND FOURTH ROW FROM THE DISTAL END. SOME OF THE STENT STRUTS WERE BULGING OUTWARDLY. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. A RECOMMENDED SIZED GUIDEWIRE (0.014 INCH) WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE ROOT CAUSE IS DETERMINED TO BE OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD THAT THE PT ANATOMY OR OTHER PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMITED THE PERFORMANCE OF THE DEVICE. A CAPA HAS BEEN INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    DETERMINED TO BE REPORTABLE BASED ON ANALYSIS COMPLETED ON 03/26/2008. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), THERE WAS DIFFICULTY CROSSING THE LESION. THE LESION BEING TREATED WAS MODERATELY CALCIFIED AND TORTUOUS, 90% STENOSED WITH ANGULATIONS IN THE DISTAL RIGHT CORONARY ARTERY. THE PHYSICIAN USED A MAVERICK 2 BALLOON 2.50/20 FOR PRE-DILATION. WHEN HE DELIVERED THE 3.00X20MM TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT, THERE WAS RESISTANCE MET AND HE COULD NOT CROSS THE LESION. HE USED THE BUDDY WIRE AND STILL FAILED TO CROSS THE LESION; THEREFORE, THE DEVICE WAS REMOVED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PT STATUS IS LISTED AS STABLE. DEVICE ANALYSIS INDICATES STENT DAMAGE.

    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 3.00 X 20 MM 9818360

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR