BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2920394 · Received January 17, 2013

    Report

    Report Number
    2134265-2012-08553
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    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

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE STENT DELIVERY SYSTEM AND STENT WITH THE STENT PROTECTOR AND PRODUCT MANDREL PARTIALLY LOADED. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE PRESENCE OF CONTRAST IN THE INFLATION LUMEN, AND THE POSITION OF THE STENT PROTECTOR AND PRODUCT MANDREL SUGGEST THE STENT PROTECTOR AND PRODUCT MANDREL WERE REPLACED AFTER THE REPORTED OBSERVATION OF STENT DAMAGE DURING INTRODUCTION. THE STENT WAS CENTERED BETWEEN THE MARKERBANDS ON THE TIGHTLY FOLDED BALLOON; THERE WAS NO INDICATION THE DEVICE WAS SUBJECTED TO POSITIVE (INFLATION) PRESSURE. THE FIRST STENT STRUT ROW FROM THE DISTAL END OF THE STENT HAD TWO STENT STRUTS STRETCHED AND BENT. THERE WAS DISTAL TIP DAMAGE. MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ADVANCING DIFFICULTY OR THE CONFIRMED STENT AND TIP DAMAGE. A THOROUGH ANALYSIS OF THE RETURNED DEVICE COULD NOT CONFIRM THE REPORTED ADVANCING DIFFICULTY. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. A 2.5X24MM TAXUS LIBERTE STENT WAS ADVANCED FOR TREATMENT INTENDED FOR THE LEFT ANTERIOR DESCENDING ARTERY. HOWEVER, DURING INTRODUCTION OF THE STENT THROUGH THE Y CONNECTOR, THE PHYSICIAN EXPERIENCED RESISTANCE. UPON OBSERVATION, IT WAS NOTED THAT THE STENT STRUTS FLARED ON THE DISTAL END OF THE STENT CAUSING THE RESISTANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. A 2.5X24MM TAXUS LIBERTE STENT WAS ADVANCED FOR TREATMENT INTENDED FOR THE LEFT ANTERIOR DESCENDING ARTERY. HOWEVER DURING INTRODUCTION OF THE STENT THROUGH THE Y CONNECTOR, THE PHYSICIAN EXPERIENCED RESISTANCE. UPON OBSERVATION, IT WAS NOTED THAT THE STENT STRUTS FLARED ON THE DISTAL END OF THE STENT CAUSING THE RESISTANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26703 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894024250 15127139

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR