BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ ELEMENT¿

    MDR report key: 2904239 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08293
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 25, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE NOTED STENT DAMAGE. STRUTS IN THE MIDDLE OF THE STENT WERE SLIGHTLY RAISED AND MISALIGNED. NO KINKS OR DAMAGE WERE NOTICED 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 POSITIVE PRESSURE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL / PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT IS REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2012. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT WOULD NOT CROSS THE LESION. THE PHYSICIAN ADVANCED A 3.5X24MM TAXUS ELEMENT STENT TO TREAT THE 90% STENOSED TARGET LESION LOCATED IN THE SEVERELY TORTUOUS RIGHT CORONARY ARTERY BUT WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD. HOWEVER, ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT THERE WAS STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10492 TAXUS¿ ELEMENT¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902524350 14411271

    Patients

    Seq Age Sex Outcome Treatment
    1