BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2792547 · Received October 16, 2012

    Report

    Report Number
    2134265-2012-06409
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    August 13, 2012
    Report Date
    September 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    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 COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: A VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED BLOOD AND CONTRAST IN THE GUIDE WIRE LUMEN. THE STENT WAS CENTERED BETWEEN THE MARKERBANDS ON THE TIGHTLY FOLDED BALLOON; THERE WAS NO INDICATION THE DEVICE WAS SUBJECTED TO POSITIVE (INFLATION) PRESSURE. THE HYPOTUBE WAS DETACHED/SEPARATED 55CM FROM THE STRAIN RELIEF. MICROSCOPIC EXAMINATION OF THE MATERIAL SURROUNDING THE HYPOTUBE BREAK DID NOT REVEAL ANY INHERENT DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE INCIDENT. THERE WAS DISTAL TIP DAMAGE. MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CROSSING DIFFICULTY OR THE DEVICE DAMAGE. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS 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 PERCUTANEOUS CORONARY INTERVENTION, A CATHETER WAS UNABLE TO CROSS A LESION. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 10MM LONG TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER PRE-DILATATION WITH AN UNSPECIFIED BALLOON TO 16 ATMS, THE 28 X 3.00MM TAXUS LIBERTE STENT DELIVERY SYSTEM WAS INTRODUCED BUT WAS UNABLE TO CROSS THE TARGET LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.0 X 28MM TAXUS LIBERTE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. DEVICE ANALYSIS REVEALED A SHAFT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894028300 14991072

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR