BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 872137 · Received March 16, 2007

    Report

    Report Number
    6000089-2007-00410
    Event Type
    Malfunction
    Date Received
    March 16, 2007
    Report Date
    November 17, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    p030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A DETAILED DEVICE ANALYSIS, THE COMPLAINT INVESTIGATION SITE (CIS) COULD CONFIRM THE COMPLAINT INCIDENT. ATTEMPTS TO INFLATE THE BALLOON USING AN ENCORE INFLATION DEVICE WERE UNSUCCESSFUL DUE TO A LONGITUDINAL TEAR AT THE PORT. MICROSCOPIC EXAMINATION OF THE DEVICE REVEALED DAMAGE TO THE MIDSHAFT. THE MIDSHAFT WAS TORN LONGITUDINALLY AND WAS STRETCHED FOR APPROXIMATELY 1CM DISTAL TO THE PORT REGION. THE BALLOON, CRIMPED STENT 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 DID NOT APPEAR TO HAVE BEEN SUBJECTED TO ANY POSITIVE PRESSURE. A REVIEW OF THE TOP ASSEMBLY SHOP FLOOR PAPERWORK FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 8832072 AND SUB-ASSEMBLY BATCH # 8828399 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE ROOT CAUSE OF THE COMPLAINT INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON 3/15/2007. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, BALLOON INFLATION FAILED. THE PHYSICIAN ATTEMPTED TO PLACE A TAXUS EXPRESS2 2.5 X 16MM DRUG ELUTING STENT TO AN UNK VESSEL, BUT WAS UNABLE TO INFLATE THE BALLOON. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. HOWEVER, THE RETURNED PRODUCT REVEALED A LONGITUDINAL TEAR AT THE PORT OF THE BALLOON.

    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 2.5X16MM 8832072

    Patients

    Seq Age Sex Outcome Treatment
    1 *