BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2100958 · Received May 24, 2011

    Report

    Report Number
    2134265-2011-01923
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT MIGRATION OCCURRED. THE STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN EXPERIENCED DIFFICULTY CROSSING THE LESION WITH THE 2.25X32MM TAXUS LIBERTE STENT. WHEN THE PHYSICIAN ATTEMPTED TO "RELEASE" THE STENT, IT DISLODGED FROM THE DELIVERY SYSTEM. THE STENT WAS FOUND IN A VESSEL IN THE 'UPPER LIMBS', EXPANDED. A 2.25X28MM TAXUS LIBERTE STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE 2.25X28MM, SEVERELY CALCIFIED LESION BEING TREATED CONTAINED A >45 TO <90 DEGREE BEND. THE LESION WAS NOT PREDILATED. NO ATTEMPT WAS MADE TO RETRIEVE THE STENT.

    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 H7493894032220 0014107154

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention