BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1170151 · Received September 11, 2008

    Report

    Report Number
    2134265-2008-02603
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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

    FOLLOWING A DETAILED DEVICE ANALYSIS, IT WAS NOTED THAT THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. THE DEVICE WAS RETURNED FOR ANALYSIS AND INITIAL VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED PROXIMAL STENT DAMAGE. TWO OF THE STRUTS WERE BENT BACK DISTALLY. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE DEVICE ENCOUNTERING SOME FORM OF RESTRICTION ON THE WITHDRAWAL OF THE DEVICE. NO KINKS OR DAMAGE WERE FOUND ON THE HYPOTUBE. 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 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. ALL UNITS SHIPPED FOR THE BATCH CONFORMED TO PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON 08/19/2008. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT COULD NOT CROSS THE 90% STENOSED, SEVERELY CALCIFIED, AND EXTREMELY TORTUOUS DISTAL CIRCUMFLEX LESION. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 2.75X32MM 11623782

    Patients

    Seq Age Sex Outcome Treatment
    1