BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1980296 · Received February 7, 2011

    Report

    Report Number
    2134265-2011-00134
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: EXAMINATION OF THE RETURNED DEVICE OBSERVED CONTRAST AND BLOOD IN THE DISTAL AND MIDSHAFT OF THE DEVICE AND REVEALED THAT ROWS 1, 2, 13, 14 AND 20 OF THE DISTAL STRUTS WERE DAMAGED AND EXTENDING BACK UP TO 90 DEGREES. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 2.75X38MM TAXUS LIBERTE STENT TO THE LESION AND WAS UNABLE TO CROSS. UPON REMOVAL IT WAS NOTED THAT THE STENT GOT LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS REPORTED AS GOOD.

    Description of Event or Problem · 1

    WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 2.75X38MM TAXUS LIBERTE STENT TO THE LESION AND WAS UNABLE TO CROSS. UPON REMOVAL IT WAS NOTED THAT THE STENT GOT LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893638270 13795630

    Patients

    Seq Age Sex Outcome Treatment
    1