BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1172546 · Received September 19, 2008

    Report

    Report Number
    2134265-2008-02733
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    July 14, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A DETAILED DEVICE ANALYSIS BY THE COMPLAINT INVESTIGATION SITE IT WAS NOTED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE DISTAL EDGE OF THE STENT WAS DAMAGE. THE STRUTS ON THE FIRST DISTAL STENT ROW WERE SLIGHTLY RAISED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE DELIVERY SYSTEM ENCOUNTERING SOME FORM OF RESTRICTION. NO KINKS OR DAMAGE WERE NOTED 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 REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET TIS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY IS DETERMINED TO THE OPERATIONAL CONTEXT DUE TO THE ANATOMICAL AND/OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PRODUCE.

    Description of Event or Problem · 1

    THIS EVENT IS REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED IN 2008. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PHYSICIAN COULD NOT CROSS THE LESION WITH A TAXUS EXPRESS2 3.50X12MM DRUG ELUTING STENT IN THE CIRCUMFLEX. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. HOWEVER, THE RETURNED PRODUCT CONFIRMED THAT THERE WAS 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 CORPORATION 3.50X12MM 0011534629

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR