BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1832826 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-04026
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 24, 2010
    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

    (B)(4) - THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS, SEVERELY CALCIFIED MID TO DISTAL RIGHT CORONARY ARTERY (RCA). PREDILATION WAS PERFORMED WITH A 1.5MM MAVERICK2 BALLOON. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED; HOWEVER, NO CROSS AND LOST IMAGE OCCURRED UPON ATTEMPT TO CROSS THE LESION. PREDILATION WAS AGAIN PERFORMED WITH AN UNKNOWN 2.5X12MM BALLOON. IVUS WAS PERFORMED. THE PHYSICIAN INTRODUCED THE 3.50X32MM TAXUS LIBERTE STENT AND NO CROSS OCCURRED AFTER SEVERAL ATTEMPTS TO CROSS THE LESION. IT WAS NOTED THAT STENT DAMAGE OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893632350 12802328

    Patients

    Seq Age Sex Outcome Treatment
    1