BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2833448 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-06944
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, INCOMPLETE STENT APPOSITION OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. A 2.50X20MM PROMUS ELEMENT STENT WAS DEPLOYED. DURING IVUS, IT WAS NOTED THAT THE STENT WAS NOT PROPERLY APPOSED. THE PHYSICIAN ATTEMPTED TO USE A 5.5 /15/153 MAVERICK XL BALLOON TO POST DILATE, BUT WAS UNABLE TO CROSS. THE STENT WAS POST DILATED WITH A NC QUANTUM APEX BALLOON. THEN THE STENT WAS APPOSED FOLLOWING POST-DILATATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320350 15346510

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention