BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS (TM) LIBERTÉ (TM)

    MDR report key: 2231797 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03736
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    April 30, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: RECEIVED PRODUCT CONSISTED OF A TAXUS LIBERTE MONORAIL STENT DELIVERY SYSTEM (SDS) AND STENT. THE SDS WAS RECEIVED IN FOUR PIECES (MANIFOLD/STRAIN RELIEF, 19.5 CM, 25 CM, 82 CM (DISTAL PORTION)). THE SHAFT OF THE DEVICE PRESENTED KINKS THROUGHOUT THE ENTIRE LENGTH. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT POSITIONED BETWEEN THE MARKERBANDS. FURTHER INSPECTION 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/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT BROKEN DURING THE PROCEDURE.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE DEVICE WAS UNABLE TO CROSS THE LESION. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS, MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. THE LESION WAS PREDILATED WITH A 2.0X 9MM UNSPECIFIED BALLOON. THE 3.0 X 12MM TAXUS LIBERTE (MR) STENT DELIVERY SYSTEM WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPETED WITH A DIFFERENT DEVICE AND THE PATIENT'S STATUS WAS REPORTED AS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THE SHAFT WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (TM) LIBERTÉ (TM) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894012300 13537756

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR