BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1242908 · Received November 19, 2008

    Report

    Report Number
    2134265-2008-04382
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    August 14, 2008
    Report Date
    October 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED. ONE STRUT ON THE FIRST STENT ROW FROM THE DISTAL EDGE WAS RAISED SLIGHTLY. THERE WERE SEVERE KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. 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 ANY POSITIVE PRESSURE. A RECOMMENDED SIZED PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. 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 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 10/21/2008. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) DRUG ELUTING STENTING TREATMENT THE PHYSICIAN WAS UNABLE TO CROSS THE LESION. THE 90% STENOTIC LESION WAS LOCATED IN THE CALCIFIED AND MILDLY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN PREDILATED THE LESION THEN ADVANCED THE 2.50X16MM TAXUS EXPRESS2 STENT TO THE LESION, BUT WAS UNABLE TO CROSS. THERE WERE NO PT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. PT STATUS IS REPORTED AS "GOOD." HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THERE WAS DISTAL STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.50X16MM 9664554

    Patients

    Seq Age Sex Outcome Treatment
    1