BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1760807 · Received July 19, 2010

    Report

    Report Number
    2134265-2010-03054
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 21, 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

    (B)(4)DEVICE EVLUATED 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 - A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED PROXIMAL STENT DAMAGE. ON ROW 1 THE STRUTS WERE RAISED PROXIMALLY. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. 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 POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED NO KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. A PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION 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 DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90-95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL CIRCUMFLEX (CX) ARTERY. THE LESION WAS 18MM IN LENGTH AND THE REFERENCE VESSEL DIAMETER WAS 2.50-2.75MM. INITIALLY A MAVERICK BALLOON WAS ADVANCED BUT WOULD NOT CROSS THE LESION. NEXT THE PHYSICIAN ATTEMPTED TO ADVANCE A TAXUS LIBERTE 2.50X20MM STENT BUT WAS ALSO UNABLE TO CROSS THE LESION. THE EDGE OF THE STENT STRUT WAS DAMAGED. BOTH THE BALLOON AND THE STENT DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT. A NON-BSC 1.25MM BALLOON WAS USED TO DILATE THE LESION AND THE RESIDUAL STENOSIS WAS 65-75%. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS REPORTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90-95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL CIRCUMFLEX (CX) ARTERY. THE LESION WAS 18MM IN LENGTH AND THE REFERENCE VESSEL DIAMETER WAS 2.50-2.75MM. INITIALLY A MAVERICK BALLOON WAS ADVANCED BUT WOULD NOT CROSS THE LESION. NEXT THE PHYSICIAN ATTEMPTED TO ADVANCE A TAXUS LIBERTE 2.50X20MM STENT BUT WAS ALSO UNABLE TO CROSS THE LESION. THE EDGE OF THE STENT STRUT WAS DAMAGED. BOTH THE BALLOON AND THE STENT DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT. A NON-BSC 1.25MM BALLOON WAS USED TO DILATE THE LESION AND THE RESIDUAL STENOSIS WAS 65-75%. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS REPORTED AS STABLE.

    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 H7493894020250 13164938

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR