BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1883603 · Received October 26, 2010

    Report

    Report Number
    2134265-2010-04747
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    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 MFR.: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE (MR) STENT DELIVERY SYSTEM (SDS) IN TWO PIECES. CONTRAST AND BLOOD WERE VISIBLE IN THE DISTAL AND MIDSHAFT OF THE DEVICE WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS USED. IT WAS DETERMINED THAT THE HYPOTUBE WAS BROKEN 14.5CM. FROM THE STRAIN RELIEF. MICROSCOPIC EXAMINATION OF THE MATERIAL SURROUNDING THE HYPOTUBE BREAK DID NOT REVEAL ANY INHERENT DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE INCIDENT. THE RETURNED CATHETER WAS VISUALLY AND TACTILELY EXAMINED ALONG THE ENTIRE LENGTH OF THE SHAFT AND NO OTHER DAMAGE WAS SEEN OTHER THAN THE BROKEN HYPOTUBE. 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).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE CALCIFIED AND TORTUOUS CIRCUMFLEX ARTERY (CX) AND THE LESION WAS PREDILATED WITH AN APEX BALLOON. IT WAS NOTED THAT THE PROXIMAL PORTION OF THE SHAFT BROKE OUTSIDE THE PATIENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE CALCIFIED AND TORTUOUS CIRCUMFLEX ARTERY (CX) AND THE LESION WAS PREDILATED WITH AN APEX BALLOON. IT WAS NOTED THAT THE PROXIMAL PORTION OF THE SHAFT BROKE OUTSIDE THE PATIENT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A SHAFT BREAK OCCURRED. THE PHYSICIAN ADVANCED A 2.50X8MM TAXUS LIBERTE STENT TO THE DIAGONAL ARTERY AND DURING THE ATTEMPT TO CROSS THE LESION, THE SHAFT OF THE TAXUS LIBERTE STENT DELIVERY SYSTEM BROKE. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE DEVICE FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    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 - MAPLE GROVE H749389368250 13329384

    Patients

    Seq Age Sex Outcome Treatment
    1