BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3220742 · Received July 11, 2013

    Report

    Report Number
    2134265-2013-04712
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED STENT DAMAGE. THE STRUTS ON THE FIRST ROWS ROW ON THE DISTAL END OF THE STENT WERE MISALIGNED. THE BALLOON AND THE TIP 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 POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE STENT DAMAGE WAS OBSERVED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX). THE LESION WAS PREDILATED WITH A 2.0X15MM APEX BALLOON. WHILE UNPACKING THE 20 X 2.25MM TAXUS LIBERTE STENT IT WAS DISCOVERED THAT THE STENT WAS NOT SMOOTH. THE DEVICE NEVER ENTERED THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CURRENT CONDITION IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE STENT DAMAGE WAS OBSERVED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX). THE LESION WAS PREDILATED WITH A 2.0X15MM APEX BALLOON. WHILE UNPACKING THE 20 X 2.25MM TAXUS LIBERTE STENT IT WAS DISCOVERED THAT THE STENT WAS NOT SMOOTH. THE DEVICE NEVER ENTERED THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CURRENT CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320603 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894020220 15004648

    Patients

    Seq Age Sex Outcome Treatment
    1