BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3243630 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-04926
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A SHAFT HYPOTUBE BREAK LOCATED 44.5 CM FROM THE CATHETER STRAIN RELIEF. THE CRIMPED STENT, BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. 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) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, SHAFT KINK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE 32MM IN LENGTH, DE NOVO, TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY WITH A REFERENCE DIAMETER OF 2.5MM. A 32MM X 2.50MM TAXUS LIBERTÉ STENT WAS ADVANCED BUT THE PUSHING ROD OF THE DEVICE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED HYPOTUBE BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342853 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894032250 14906928

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR