BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3102339 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03111
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 4, 2013
    Report Date
    April 11, 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 EVALUATED BY MFR: THE DEVICE WAS RETURNED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE SHAFT APPROXIMATELY 681MM DISTAL FROM THE CATHETERS STRAIN RELIEF. A VISUAL AND MICROSCOPIC EXAMINATION FOUND NO ISSUES WITH THE DEVICE. THE CRIMPED STENT, BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO FURTHER DAMAGE WAS NOTED WHICH COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. 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

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT BROKE. THE 80% RESTENOSED, ECCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER PRE-DILATION, A 12MM X 4.50MM TAXUS LIBERTE STENT WAS USED TO TREAT THE TARGET LESION. DURING THE ADVANCING OF THE STENT THE SHAFT BROKE APPROXIMATELY 60CM FROM THE HUB. THE SHAFT WAS SUCCESSFULLY REMOVED WITH THE GUIDING CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATION AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT BROKE. THE 80% RESTENOSED, ECCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER PRE-DILATION, A 12MM X 4.50MM TAXUS LIBERTE STENT WAS USED TO TREAT THE TARGET LESION. DURING THE ADVANCING OF THE STENT THE SHAFT BROKE APPROXIMATELY 60CM FROM THE HUB. THE SHAFT WAS SUCCESSFULLY REMOVED WITH THE GUIDING CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATION AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202769 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894012450 15042249

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR