BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ (TM)

    MDR report key: 2163057 · Received July 15, 2011

    Report

    Report Number
    2134265-2011-02693
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED THAT THE HYPOTUBE WAS KINKED AT 4.3CM DISTAL TO THE STRAIN RELIEF. THIS KINK IS CONSISTENT WITH EXCESSIVE FORCE HAVING BEEN APPLIED TO THE SHAFT. AN EXAMINATION OF THE CRIMPED STENT IDENTIFIED THAT SOME STENT STRUTS WERE LIFTED IN THE MID TO PROXIMAL SECTION OF THE STENT. NO OTHER DAMAGE WAS VISIBLE WITH THIS DEVICE. THE BALLOON DID NOT APPEAR TO HAVE BEEN SUBJECTED TO ANY POSITIVE PRESSURES. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE "TYPE A" LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY (RCA). DIRECT STENTING WAS ATTEMPTED USING A 2.50X12MM LIBERTE BARE METAL STENT DELIVERY SYSTEM, HOWEVER, RESISTANCE WAS FELT. THE PHYSICIAN WITHDREW THE STENT DELIVERY SYSTEM AND NOTICED SOME OF THE STENT STRUTS WERE TORN AWAY FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE ''TYPE A'' LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY (RCA). DIRECT STENTING WAS ATTEMPTED USING A 2.50X12MM LIBERTE BARE METAL STENT DELIVERY SYSTEM, HOWEVER, RESISTANCE WAS FELT. THE PHYSICIAN WITHDREW THE STENT DELIVERY SYSTEM AND NOTICED SOME OF THE STENT STRUTS WERE TORN AWAY FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTÉ (TM) STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893812250 14072279

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR