BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1963251 · Received January 19, 2011

    Report

    Report Number
    2134265-2011-00111
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATION: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE STENT DELIVERY SYSTEM CATHETER. THE STENT HAD MOVED 1MM FROM THE PROXIMAL MARKERBAND. A STRUT IN THE SIXTH PROXIMAL ROW WAS LIFTED. THE MAJORITY OF THE STENT WAS MANGLED AND STRETCHED 30MM PAST THE TIP. MICROSCOPIC INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 2.25X20MM TAXUS LIBERTE STENT TO THE LESION BUT WAS UNABLE TO CROSS. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.25X20MM TAXUS LIBERTE STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THERE WAS STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893620220 13397754

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR