BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ ELEMENT¿

    MDR report key: 3021533 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-01628
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    November 7, 2012
    Report Date
    February 25, 2013
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - INITIAL VISUAL EXAMINATION OF THE RETURNED DEVICE, FOUND PROXIMAL STENT STRUT DAMAGE PRESENT, AS A NUMBER OF STRUTS WERE BENT BACK DISTALLY. 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. NO FURTHER DAMAGE WAS NOTED WITH THE RETURNED DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT 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

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2013. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE 2.50X24MM TAXUS ELEMENT STENT WOULD NOT CROSS THE LESION. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED, 24MM IN LENGTH, LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH AN UNKNOWN SEMI COMPLIANT BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, THE PRODUCT ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123254 TAXUS¿ ELEMENT¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902524250 15027015

    Patients

    Seq Age Sex Outcome Treatment
    1