BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ (TM)

    MDR report key: 2233229 · Received September 2, 2011

    Report

    Report Number
    2134265-2011-03734
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE DELIVERY DEVICE WAS RECEIVED FOR ANALYSIS WITH THE STENT DETACHED FROM THE BALLOON. THE STENT WAS RECEIVED IN A PLASTIC CONTAINER. AN EXAMINATION OF THE DELIVERY DEVICE IDENTIFIED THAT THE HYPOTUBE WAS KINKED AT 15.8CM DISTAL TO THE STRAIN RELIEF. AN EXAMINATION OF THE BALLOON FOUND A CLEAR IMPRESSION OF THE STENT CRIMP ON THE BALLOON MATERIAL. THE BALLOON DID NOT APPEAR TO HAVE BEEN SUBJECTED TO ANY POSITIVE PRESSURES. THE STENT WAS REMOVED FROM THE PLASTIC CONTAINER AND IT WAS NOTED THAT THE STENT STRUTS WERE STRETCHED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS CORONARY INTERVENTION STENT DISLODGEMENT OCCURRED. AS THE PHYSICIAN REMOVED THE 3.5X16MM LIBERTE STENT FROM THE PROTECTIVE HOOP THE STENT DISLODGED FROM THE BALLOON. PROCEDURE WAS COMPLETED WITH ANOTHER 3.5X16MM LIBERTE STENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CURRENT CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS CORONARY INTERVENTION, STENT DISLODGEMENT OCCURRED. AS THE PHYSICIAN REMOVED THE 3.5X16MM LIBERTE STENT FROM THE PROTECTIVE HOOP THE STENT DISLODGED FROM THE BALLOON. PROCEDURE WAS COMPLETED WITH ANOTHER 3.5X16MM LIBERTE STENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTÉ (TM) STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893816350 14244043

    Patients

    Seq Age Sex Outcome Treatment
    1