BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1083389 · Received July 28, 2008

    Report

    Report Number
    2134265-2008-02107
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE PROXIMAL EDGE OF THE STENT WAS DAMAGED. STENT ROWS 1 AND 2 FROM THE PROXIMAL EDGE WERE RAISED DISTALLY. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. A RECOMMENDED SIZED PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. 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. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE IS DETERMINED TO BE OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PHYSICIAN WAS PLANNING TO PLACE THE TAXUS EXPRESS2 2.5X8MM DRUG ELUTING STENT TO THE HIGHLY CALCIFIED, MILDLY TORTUOUS, MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, BUT WHILE PREPARING FOR THE PROCEDURE, IT WAS NOTED THAT THE STENT WAS BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER TAXUS STENT, SAME SIZE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS POST PROCEDURE IS NOTED AS OK.

    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 2.5X8MM 11089058

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR