BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1213731 · Received October 22, 2008

    Report

    Report Number
    2134265-2008-03091
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE PROXIMAL EDGE OF THE STENT WAS DAMAGED. STRUTS ON THE FIRST STENT ROW FROM THE PROXIMAL EDGE WERE 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 NOTICED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. A RECOMMENDED SIZED PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. SOLIDIFIED CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE, INDICATING THE DEVICE HAD BEEN PREPPED FOR USE. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY IS DETERMINED TO BE OPERATIONAL CONTEXT DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    THIS EVENT IS REPORTABLE BASED ON THE PRODUCT ANALYSIS APPROVED ON 09/30/2008. IT WAS REPORTED THAT DURING A DRUG ELUTING STENTING PROCEDURE, THE STENT WOULD NOT CROSS THE LESION. THE 80% STENOTIC LESION WAS LOCATED IN THE PROXIMAL TO MID LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN ADVANCED THE 2.50X28MM TAXUS LIBERTE STENT TO THE LESION, BUT WAS UNABLE TO CROSS. THERE WERE NO PATIENT WITH A PLAIN OLD BALLOON ANGIOPLASTY. PATIENT STATUS IS REPORTED AS "GOOD." HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THERE WAS STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 2.50X28MM 11610580

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR