BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1844932 · Received September 27, 2010

    Report

    Report Number
    2134265-2010-04194
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE (MR) STENT DELIVERY SYSTEM 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 55CM 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 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 CLASSIFICATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).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)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. A 2.5X16MM TAXUS LIBERTE' STENT WAS PREPPED IN THE NORMAL FASHION. DURING INSERTION OF THE DEVICE A KINK WAS NOTED IN THE MID SHAFT AND STRAIGHTENED. WHEN THE DEVICE WAS ADVANCING THROUGH THE TOUGHY OUTSIDE THE PATIENT, THE SHAFT FRACTURED AT THE LOCATION OF THE KINK. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS LIBERTE' STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. A 2.5X16MM TAXUS LIBERTE' STENT WAS PREPPED IN THE NORMAL FASHION. DURING INSERTION OF THE DEVICE A KINK WAS NOTED IN THE MID SHAFT AND STRAIGHTENED. WHEN THE DEVICE WAS ADVANCING THROUGH THE TOUGHY OUTSIDE THE PATIENT, THE SHAFT FRACTURED AT THE LOCATION OF THE KINK. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS LIBERTE' STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS FINE.

    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 H7493893616250 13176143

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR