BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2243916 · Received September 12, 2011

    Report

    Report Number
    2134265-2011-03853
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    June 28, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE HYPOTUBE HAD BROKEN 319MM DISTAL FROM THE CATHETER'S STRAIN RELIEF. THERE WERE KINKS IDENTIFIED ON THE HYPOTUBE NEAR THE BREAKSITE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE CRIMPED STENT, BALLOON AND TIP SECTIONS OF THE DEVICE WERE 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 POSITIVE PRESSURE. ATTEMPTS TO INSERT A 0.015 INCH PRODUCT MANDREL WERE UNSUCCESSFUL DUE TO SOLIDIFIED BLOOD PRESENT WITHIN THE ENTIRE LENGTH OF THE LUMEN. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER/USE ERROR, COMPLAINT REPORT STATES THAT THE LESION WAS SEVERELY CALCIFIED. HEAVILY CALCIFIED LESIONS ARE CONTRAINDICATED IN THE DFU. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE ANALYSIS COMPLETED (B)(6) 2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE 2.75X32MM TAXUS LIBERTE MR STENT WOULD NOT CROSS THE LESION. ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE 80% STENOSED, 2.75X10MM PROGRESSIVE AND ECCENTRIC TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN ADVANCED THE STENT DELIVERY SYSTEM AND THE DEVICE AND WAS NOT ABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75X32MM TAXUS LIBERTE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS STABLE. RETURNED PRODUCT ANALYSIS REVELED SHAFT FRACTURE. ADDITIONAL FOLLOW UP REVELED THAT THE SHAFT FRACTURED WHILE ADVANCING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894032270 0013516163

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR