BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS (TM) LIBERTÉ (TM)

    MDR report key: 2221190 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03558
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 7, 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 EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED THAT THE TIP OF THE DEVICE WAS SLIGHTLY FLARED. STENT STRUTS FROM THE MOST PROXIMAL ROW WERE BENT OUTWARDS DISTALLY. THE BALLOON SECTION OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. SOLIDIFIED BLOOD WAS PRESENT ON THE OUTSIDE OF THE BALLOON. THE HYPOTUBE WAS KINKED ALONG ITS ENTIRE LENGTH. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE STENT AND BALLOON DAMAGE OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00X16MM TAXUS LIBERTE STENT DELIVERY SYSTEM WAS PREPPED AND FOUND TO HAVE PROXIMAL STENT DAMAGE AND A KINK IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE STENT AND BALLOON DAMAGE OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00X16MM TAXUS LIBERTE STENT DELIVERY SYSTEM WAS PREPPED AND FOUND TO HAVE PROXIMAL STENT DAMAGE AND A KINK IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (TM) LIBERTÉ (TM) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894016450 14299690

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR