BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2831336 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-06938
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 19, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE IS A COMBINATION PRODUCT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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 PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS PROXIMAL TO DISTAL RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED WITH A NON-BSC BALLOON CATHETER. A NON-BSC IMAGING SYSTEM WAS THEN USED TO VISUALIZE THE TARGET LESION. A 3.5 X 20 MM PROMUS ELEMENT STENT WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION; HOWEVER, THE DEVICE WAS NOT ABLE TO CROSS THE LESION. IT WAS THEN NOTED THAT THE EDGE OF THE STENT APPEARED LIFTED UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320350 15258803

    Patients

    Seq Age Sex Outcome Treatment
    1