BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS (TM) LIBERTÉ (TM)

    MDR report key: 2211400 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03217
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 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. (B)(4).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM CORRECTED. DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED PROXIMAL STENT DAMAGE. A STRUT ROW AT THE PROXIMAL END OF THE STENT WAS RAISED AND MISALIGNED. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE GUIDEWIRE LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. THE TIP AND BALLOON 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. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 75% STENOSED, 18MM IN LENGTH AND 2.5MM IN DIAMETER TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH A 1.50X15MM APEX BALLOON CATHETER, LEAVING LESS THAN 45% RESIDUAL STENOSIS IN THE LESION. A 2.50X20MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED TO THE LAD AND WOULD NOT CROSS THE LESION. WHEN THE PHYSICIAN WITHDREW THE DEVICE IT WAS NOTED THAT SOME OF THE STENT STRUTS WERE LIFTED. THE PROCEDURE WAS COMPLETED BY PREDILATION WITH A 2.75X12MM QUANTUM BALLOON CATHETER AND A 2.50X18MM NON-BSC STENT WAS DEPLOYED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE TORTUOUSITY WAS MODERATE, HOWEVER ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE TORTUOUSITY OF THE TARGET LESION WAS SEVERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (TM) LIBERTÉ (TM) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894020250 0014269982

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 1.5X15MM APEX BALLOON CATHETER