BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2872911 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07817
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    September 12, 2012
    Report Date
    November 19, 2012
    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 (B)(4). DEVICE EVALUATED BY MFR: VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED A SEVERE KINK LOCATED APPROXIMATELY 13.5MM PROXIMAL TO THE EXCHANGE PORT. THE PROXIMAL EDGE OF THE STENT WAS ALSO DAMAGED WITH A NUMBER OF STRUTS BENT BACK DISTALLY. 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 POSITIVE PRESSURE. NO FURTHER ISSUES WERE NOTED WITH THE RETURNED DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE MOST PROBABLE CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE IS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2012. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, FAILURE TO CROSS THE LESION OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.25X32MM TAXUS LIBERTE STENT WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE. HOWEVER, THE RETURNED DEVICE REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894032220 14661768

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR