BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 4093414 · Received September 16, 2014

    Report

    Report Number
    2134265-2014-05456
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    May 17, 2014
    Report Date
    August 22, 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 A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS WITH THE STENT PROTECTOR AND PRODUCT MANDREL INSERTED. THE DEVICE WAS RECEIVED IN TWO HALVES. A HYPOTUBE BREAK WAS IDENTIFIED 488MM DISTAL TO THE STRAIN RELIEF. THE BREAK SITE WAS MICROSCOPICALLY EXAMINED AND THERE WAS EVIDENCE OF MATERIAL RESISTANCE. THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. IT WAS ALSO NOTED THAT THE STRUT ROWS IN THE MIDDLE SECTION OF THE STENT WERE RAISED AND MISALIGNED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE DURING THE ADVANCEMENT OR REMOVAL OF THE DEVICE FROM THE PATIENT. THE STENT PROTECTOR WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILE. THE TIP OUTER DIAMETER WAS MEASURED USING A DIGITAL SNAP GAUGE AND WAS WITHIN SPECIFICATION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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 CROSSING DIFFICULTIES WERE ENCOUNTERED.   THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 12 X 2.75MM TAXUS¿ LIBERTÉ¿ DRUG ELUTING STENT WAS ADVANCED TO TREAT THE TARGET LESION, HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE AND THE HYPOTUBE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570989 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894012270 16604464

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR