BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1213673 · Received October 23, 2008

    Report

    Report Number
    2134265-2008-03117
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    July 14, 2008
    Report Date
    September 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A DETAILED DEVICE ANALYSIS, IT WAS NOTED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT. A REVIEW OF THE MFG DOCUMENTATION FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED. STRUTS ON STENT ROWS 1 TO 4 FROM THE DISTAL EDGE WERE RAISED AT 90 DEGREES TO THE NORMAL PLANE OF THE STRUTS. THIS DAMAGED SECTION WAS MEASURED WITH A SNAP GAUGE TO HAVE AN APPROXIMATE DIAMETER OF 1.46 MM. THIS WAS 0.34 MM GREATER THAN THE NORMAL STENT DIAMETER. 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 (0.015 INCH) WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. NO ADD'L PRODUCT ANALYSIS OR EXTERNAL EVALUATIONS WERE PERFORMED. IT IS ADVISED IN THE TAXUS LIBERTE DFU THAT IF UNUSUAL RESISTANCE IS FELT AT ANY TIME DURING LESION ACCESS BEFORE STENT IMPLANTATION, THE STENT SYSTEM AND GUIDING CATHETER SHOULD BE REMOVED AS A SINGLE UNIT. THE TARGET LESION WAS REPORTED AS HAVING CALCIFICATION AND BEING TORTUOUS. THESE COULD HAVE BEEN POTENTIAL CONTRIBUTING FACTORS TO THE COMPLAINT INCIDENT. THIS INVESTIGATION WILL BE ASSIGNED THE MOST PROBABLE ROOT CAUSE OF OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED IN 2008. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING PROCEDURE, THE STENT COULD NOT CROSS THE LESION. THE TAXUS LIBERTE STENT COULD NOT BE IMPLANTED DUE TO THE TORTUOSITY AND CALCIFICATION OF THE CIRCUMFLEX CORONARY ARTERY. THE STENT COULD NEVER REACH THE LESION, SO IT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A BARE METAL STENT. NO PT INJURIES OR COMPLICATIONS WERE REPORTED, HOWEVER, THE RETURNED PRODUCT CONFIRMED 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 2.75 X 32 MM 9398233

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR