BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2833154 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-07191
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 3.5 X 20 MM PROMUS ELEMENT STENT WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION; HOWEVER, IT WAS NOT ABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE DISTAL PART OF THE STENT APPEARED FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 14957438

    Patients

    Seq Age Sex Outcome Treatment
    1