BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1040392 · Received May 7, 2008

    Report

    Report Number
    2134265-2008-01322
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    February 28, 2008
    Report Date
    April 11, 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

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: A VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE FOUND SEVERE DAMAGE TO THE DISTAL EDGE OF THE STENT AND MID STENT DAMAGE. THE MID STENT HAD STRUTS MISALIGNED ON THREE ROWS. THE DAMAGED SECTIONS WERE MEASURED WITH A SNAP GAUGE TO HAVE THE FOLLOWING APPROXIMATE DIAMETERS: DISTAL STENT DAMAGE 1.89 MM, MID-STENT DAMAGE 1.33 MM, NORMAL SECTION 1.29 MM. ALSO, THE HYPOTUBE HAD KINKED TWICE APPROX 23.0 CM AND 25.5 CM DISTAL FROM THE CATHETERS STRAIN RELIEF. 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. A RECOMMENDED SIZED GUIDEWIRE (0.014 INCH) WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. AS THE PRODUCT MEETS THE DESIGN AND MANUFACTURE SPEC BUT DUE TO THE LIKELIHOOD THAT THE PT ANATOMY OR OTHER PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT WILL BE DOCUMENTED AS OPERATIONAL CONTEXT. A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN RAISED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS REPORTABLE BASED UPON ANALYSIS RESULTS COMPLETED ON 04/11/2008. THE PT HAD ISCHEMIC HEART DISEASE. THE LESION BEING TREATED WAS LOCATED IN 99% STENOSED AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PROX LAD). THE TAXUS EXPRESS2 3.0 X 20 MM DRUG ELUTING STENT WAS NOT ABLE TO CROSS THE CALCIFIED LESION. THE PHYSICIAN SHAPED THE STENT DELIVERY SYSTEM. HOWEVER, HE GAVE UP THE IMPLANTATION OF THE TAXUS STENT. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN SIZE LIBERTE BARE METAL STENT. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS WAS REPORTED AS "GOOD". ANALYSIS OF THE RETURNED DEVICE FOUND 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 3.0X20MM 0011150319

    Patients

    Seq Age Sex Outcome Treatment
    1 6F MEDIKIT| USCI INFLATION DEVICE| 6F MACH1 JL4 GUIDE CATHETER| RUNTHROUGH NS GUIDEWIRE| APEX 2.5X15MM BALLOON CATHETER