BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1844959 · Received September 27, 2010

    Report

    Report Number
    2134265-2010-04161
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED PROXIMAL STENT DAMAGE. STRUT ROW 1 WAS RAISED PROXIMALLY TO THE STENT. THE TIP AND BALLOON 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. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED COMPLAINT HAS BEEN DETERMINED TO BE USER RELATED AS PER THE DFU THE DEVICE IS FOR USE IN: "TREATMENT OF DE NOVO AND RESTENOTIC LESIONS OR TOTAL OCCLUSIONS IN PATIENTS WITH CORONARY ARTERY DISEASE" AND THE REPORTED INTENDED IMPLANT LOCATION LISTED FOR THIS EVENT WAS A SAPHENOUS VEIN GRAFT. THE DFU ALSO STATES THAT "WHEN TREATING MULTIPLE LESIONS, THE DISTAL LESION SHOULD BE INITIALLY STENTED, FOLLOWED BY STENTING OF THE MORE PROXIMAL LESION(S). STENTING IN THIS ORDER ALLEVIATES THE NEED TO CROSS THE PROXIMAL STENT IN PLACEMENT OF THE DISTAL STENT AND REDUCES THE CHANCES FOR DISLODGING THE PROXIMAL STENT". (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) -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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A 3.5X16MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE PROXIMAL SEGMENT OF THE STENT WOULD NOT CROSS THE VEIN GRAFT AND STENT DAMAGE WAS NOTED. HOWEVER, IT WAS FURTHER REPORTED THAT DURING THE PROCEDURE, AN UNKNOWN STENT WAS FIRST IMPLANTED IN THE PROXIMAL SECTION OF THE VEIN GRAFT. THE 3.5X16MM TAXUS LIBERTE SDS COULD NOT CROSS THIS IMPLANTED STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG). A 3.5X16MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER THE PROXIMAL SEGMENT OF THE STENT WOULD NOT CROSS THE VEIN GRAFT AND STENT DAMAGE WAS NOTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A 3.5X16MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE PROXIMAL SEGMENT OF THE STENT WOULD NOT CROSS THE VEIN GRAFT AND STENT DAMAGE WAS NOTED. HOWEVER, IT WAS FURTHER REPORTED THAT DURING THE PROCEDURE, AN UNKNOWN STENT WAS FIRST IMPLANTED IN THE PROXIMAL SECTION OF THE VEIN GRAFT. THE 3.5X16MM TAXUS LIBERTE SDS COULD NOT CROSS THIS IMPLANTED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894016350 13048223

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR