BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2822644 · Received November 7, 2012

    Report

    Report Number
    2134265-2012-06795
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 13, 2012
    Report Date
    October 13, 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

    DEVICE IS COMBINATION PRODUCT. (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED MID RIGHT CORONARY ARTERY (RCA) AT THE PROXIMAL END OF A DEPLOYED STENT. THE 3.5 X 24MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM WAS ADVANCED, BUT WAS UNABLE TO CROSS AT THE PROXIMAL SIDE OF THE LESION. UPON EXAMINATION IT WAS NOTED THAT THE PROXIMAL STENT AREA WAS FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.5 X 24MM PROMUS ELEMENT MR STENT. 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 H7493911324350 15284931

    Patients

    Seq Age Sex Outcome Treatment
    1