BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1811740 · Received August 23, 2010

    Report

    Report Number
    2134265-2010-03763
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE TAXUS LIBERTE WAS RETURNED WITH SOLIDIFIED CONTRAST MEDIA AND BLOOD PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN PREPPED AND USED IN VIVO. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED THAT THE STENT WAS DISLODGED FROM THE STENT DELIVERY SYSTEM AND DEPLOYED. THE STENT WAS DAMAGED AND MISALIGNED AT ONE END. THE BALLOON WAS RETURNED PARTIALLY INFLATED. THE BALLOON WAS SUCCESSFULLY INFLATED AND DEFLATED. THE MIDSHAFT WAS STRETCHED FROM THE PORT TO 100MM PROXIMAL TO THE PORT. EXAMINATION IDENTIFIED KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. NO ISSUES WERE NOTED TO THE TIP SECTION OF THE DEVICE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. 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). DEVICE EVALUATED BY MFR: 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

    AGE AT TIME OF EVENT: (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE 75% STENOSED LESION WAS LOCATED IN A MILDLY CALCIFIED AND MILDLY TORTUOUS VESSEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE 4.50X20MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION BUT COULD NOT CROSS. AFTER THE SDS WAS REMOVED FROM THE PATIENT THE STENT FELL OFF OF THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT CONDITION IS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE 75% STENOSED LESION WAS LOCATED IN A MILDLY CALCIFIED AND MILDLY TORTUOUS VESSEL.

    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 H7493894020450 13072590

    Patients

    Seq Age Sex Outcome Treatment
    1