BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3961965 · Received July 28, 2014

    Report

    Report Number
    2134265-2014-04415
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE NON-TOTALLY OCCLUDED TARGET LESION CONTAINED >45 AND <90 DEGREE BEND AND WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). FOLLOWING THE INTRODUCTION OF A 6FR UNSPECIFIED GUIDE CATHETER, A 3.00X20MM PROMUS ELEMENT ¿ DRUG-ELUTING STENT WAS SELECTED FOR USE AND ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND ITS PROXIMAL SEGMENT WAS NOTED TO HAVE BEEN DEFORMED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437725 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320300 16004102

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR