BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3761135 · Received April 21, 2014

    Report

    Report Number
    2134265-2014-01960
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    February 5, 2014
    Report Date
    March 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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. DEVICE EVALUATED BY MFR: THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE HYPOTUBE. THE BREAK WAS LOCATED AT 20.5CM DISTAL TO THE STRAIN RELIEF. A KINK WAS PRESENT IN THE PROXIMAL SECTION OF THE HYPOTUBE BREAK AT 2.5CM DISTAL TO THE STRAIN RELIEF. NO OTHER DAMAGE WAS NOTED ALONG THE ENTIRE LENGTH OF THE DEVICE. AN EXAMINATION OF THE CRIMPED STENT IDENTIFIED NO ISSUES. 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 BASED ON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CATHETER CROSSING DIFFICULTIES OCCURRED. THE PROCEDURE WAS INDICATED DUE TO CORONARY ARTERY DISEASE. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR ARTERY. A 12 X 3.00MM TAXUS LIBERTÉ STENT WAS ADVANCED TO TREAT THE TARGET LESION, HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A CATHETER SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240829 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894012300 16352721

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR