BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3133477 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03386
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    February 14, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WITH STENT AND NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS CONTRAST AND BLOOD UNDER THE BALLOON FOLDS AND BETWEEN THE STENT STRUTS. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON. THE FIRST, SECOND, THIRD, SEVENTH, NINTH, ELEVENTH AND THIRTEENTH ROWS OF STRUTS ON THE PROXIMAL END OF THE STENT WERE BENT, FLARED AND OVERLAPPING. 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 FACTOR. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A CORONARY STENTING PROCEDURE A STENT FAILED TO CROSS THE LESION OCCURRED. ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 28 X 2.50MM TAXUS LIBERTÉ STENT DELIVERY SYSTEM WAS SELECTED FOR TREATMENT. UPON ADVANCING OF THE COMPLAINT DEVICE, THE STENT FAILED TO CROSS THE LESION AND THE DEVICE WAS REMOVED AS A WHOLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATION WAS REPORTED AND PATIENT'S CONDITION WAS STABLE. HOWEVER RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236581 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894028250 15514620

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR