BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS (TM) LIBERTÉ (TM)

    MDR report key: 2142426 · Received June 28, 2011

    Report

    Report Number
    2134265-2011-02692
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED WITH PROXIMAL STENT DAMAGE. STRUT ROWS TOWARDS THE PROXIMAL END OF THE STENT WERE RAISED FROM THE BALLOON AND MISALIGNED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. 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. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. MANDREL RESISTANCE WAS ENCOUNTERED DUE TO THE PRESENCE OF SOLIDIFIED BLOOD WITHIN THE GUIDE WIRE LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. 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 IN PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE STENT DAMAGE OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. DURING UNPACKING OF THE 2.25 X 32MM TAXUS LIBERTE MONORAIL DRUG ELUTING STENT DELIVERY SYSTEM WHEN THE PHYSICIAN FOUND THE STENT STRUT KINKED ABOUT 6 MM TO THE PROXIMAL SECTION OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE STENT DAMAGE OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. DURING UNPACKING OF THE 2.25 X 32MM TAXUS LIBERTE MONORAIL DRUG ELUTING STENT DELIVERY SYSTEM WHEN THE PHYSICIAN FOUND THE STENT STRUT KINKED ABOUT 6 MM TO THE PROXIMAL SECTION OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT 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 H7493894032220 0014107154

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR