BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1781195 · Received August 3, 2010

    Report

    Report Number
    2134265-2010-03249
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE STENT WAS DAMAGED. STRUTS ON THE FIRST STENT ROWS FROM THE DISTAL EDGE WERE RAISED AND THE STRUTS ON STENT ROWS 1 TO 2 FROM THE PROXIMAL EDGE WERE RAISED PROXIMALLY. THE MIDSHAFT WAS KINKED FROM THE PORT AREA TO 1CM PROXIMAL TO THE PORT AREA. THERE WERE NO OTHER KINKS OR DAMAGE NOTICED ALONG THE SHAFT OF THE DEVICE. THE BALLOON AND TIP 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 ANY POSITIVE PRESSURE. NO ADDITIONAL PRODUCT ANALYSIS OR EXTERNAL EVALUATIONS WERE PERFORMED. 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 MODERATELY TORTUOUS AND CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN PREPARED THE VESSEL WITH A ROTABLATOR PROCEDURE AND THEN A 4.00X38MM TAXUS LIBERTE LONG STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE RCA SEVERAL TIMES BUT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN PREDILATED THE LESION SEVERAL TIMES WITH A QUANTUM AND APEX BALLOONS AND WAS THEN ABLE TO CROSS THE LESION WITH A 4.0X18MM PROMUS STENT. THE PHYSICIAN INTENDED TO PLACE THE 4.00X38MM TAXUS LIBERTE LONG STENT IN THE PROXIMAL RCA; HOWEVER, BEFORE ADVANCING THE SDS AGAIN IT WAS NOTED THAT THE STENT WAS DAMAGED. THE LESION WAS TREATED WITH A 4.00X16MM TAXUS STENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE MODERATELY TORTUOUS AND CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN PREPARED THE VESSEL WITH A ROTABLATOR PROCEDURE AND THEN A 4.00X38MM TAXUS LIBERTE LONG STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE RCA SEVERAL TIMES BUT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN PREDILATED THE LESION SEVERAL TIMES WITH A QUANTUM AND APEX BALLOONS AND WAS THEN ABLE TO CROSS THE LESION WITH A 4.0X18MM PROMUS STENT. THE PHYSICIAN INTENDED TO PLACE THE 4.00X38MM TAXUS LIBERTE LONG STENT IN THE PROXIMAL RCA; HOWEVER, BEFORE ADVANCING THE SDS AGAIN IT WAS NOTED THAT THE STENT WAS DAMAGED. THE LESION WAS TREATED WITH A 4.00X16MM TAXUS STENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS OKAY.

    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 H7493893638400 12804278

    Patients

    Seq Age Sex Outcome Treatment
    1