BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2153006 · Received July 7, 2011

    Report

    Report Number
    2134265-2011-02721
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. PATIENT IDENTIFIER - (B)(6). 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).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE BIFURCATED MID LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS 80% STENOSED, 4.0MM IN DIAMETER AND 16MM LONG WITH A BEND GREATER THAN 60%. PREDILATION WAS PERFORMED. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT CROSS THE LESION WITH A 3.0X20MM TAXUS ELEMENT STENT. A 3.0 X 20 TAXUS ELEMENT STENT WAS OPENED BUT NOT DEPLOYED AS THE STRUTS WERE DISRUPTED WHEN THEY CAUGHT ON THE MONORAIL INFLOW OF A NON-BSC GUIDE EXTENSION DEVICE. THE VESSEL WAS SUCCESSFULLY TREATED WITH PLACEMENT OF A 3.0 X 16 MM TAXUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902520300 13575964

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR