BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2801985 · Received October 23, 2012

    Report

    Report Number
    2134265-2012-06588
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    August 25, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED WITH A PARTIALLY LOADED PRODUCT MANDREL, WHICH WAS PLACED IN FINAL PACKAGING, INDICATING IT WAS REMOVED AND REPLACED SOMETIME AFTER UNPACKAGING. THERE WAS CONTRAST IN THE INFLATION 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. THERE WERE TWO STRUTS STRETCHED AND BENT IN THE LAST DISTAL ROW OF THE STENT. 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 CONFIRMED STENT AND TIP 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 IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE ON ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE STENT DID NOT CROSS THE LESION. VASCULAR ACCESS WAS GAINED VIA THE FEMORAL ARTERY. THE 95% STENOSED, 2.5 X 30MM CONCENTRIC DE NOVO LESION BEING TREATED WAS LOCATED IN THE NON-CALCIFIED, NON-TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATION, THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.50X32MM TAXUS LIBERTE STENT. THERE WAS DIFFICULTY CROSSING THE LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALS STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894032250 15016013

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR