BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1203638 · Received October 16, 2008

    Report

    Report Number
    2134265-2008-03047
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    July 30, 2008
    Report Date
    October 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    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 EVAL: VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED PROXIMAL AND DISTAL STENT DAMAGE. SOME OF THE PROXIMAL AND DISTAL STENT STRUTS WERE MISALIGNED. PROXIMAL STENT DAMAGE IS CONSISTENT WITH THE DEVICE ENCOUNTERING SIGNIFICANT RESISTANCE DURING THE WITHDRAWAL OF THE DEVICE. THE DISTAL STENT DAMAGE IS CONSISTENT WITH THE DEVICE ENCOUNTERING SOME FORM OF RESTRICTION DURING THE INSERTION OF THE DEVICE. NO KINKS OR DAMAGE WAS FOUND ALONG THE HYPOTUBE. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AN 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 RECOMMENDED SIZED PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. A REVIEW OF THE MFG 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 THE 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 10/14/2008. IT WAS REPORTED THAT DURING A DRUG ELUTING STENTING PROCEDURE, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE 89% STENOTIC LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED MID LEFT CIRCUMFLEX ARTERY. AFTER PREDILATING THE LESION WITH A 2.5X20MM BALLOON CATHETER, THE PHYSICIAN ATTEMPTED TO ADVANCE THE 3.50X28 TAXUS LIBERTE STENT TO THE LESION, BUT MET WITH SIGNIFICANT RESISTANCE. THE DEVICE WAS REMOVED. THERE WERE NO PT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH PLAIN OLD BALLOON ANGIOPLASTY USING A 3.0MM BALLOON. PT 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 NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 3.50X38MM 9475480

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR