BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1323495 · Received February 25, 2009

    Report

    Report Number
    2134265-2008-03793
    Event Type
    Malfunction
    Date Received
    February 25, 2009
    Date of Event
    August 15, 2008
    Report Date
    September 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND LTD.
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED. STENT ROWS ONE TO FIVE FROM THE DISTAL EDGE WERE MISALIGNED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE DELIVERY SYSTEM ENCOUNTERING SOME FORM OF RESTRICTION. 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. 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. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE IS DETERMINED TO BE OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    EVENT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON 9/8/20085. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT COULD NOT CROSS THE LESION. THE PHYSICIAN ATTEMPTED TO PLACE A TAXUS LIBERTE' 2.75X20MM DRUG ELUTING STENT TO THE DIAGONAL (DX) ARTERY, BUT WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS POST PROCEDURE IS NOTED AS STABLE. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED 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 IRELAND LTD. 2.75X20MM 9794492

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR