BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 4060484 · Received September 4, 2014

    Report

    Report Number
    2134265-2014-05245
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER.   DEVICE IS A COMBINATION PRODUCT. (B)(4).   DEVICE EVALUATED BY MFR.: THE DEVICE WAS NOT RETUNED. 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 STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED POSTERIOR DESCENDING ARTERY OF THE RIGHT CORONARY ARTERY (RCA). A 2.25X12MM PROMUS ELEMENT¿ PLUS STENT WAS SELECTED TO TREAT THE TARGET LESION; HOWEVER THE DEVICE WAS UNABLE TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE DISTAL END OF THE STENT WAS FOUND TO BE LIFTED UP. THE PROCEDURE WAS COMPLETED WITH A PROMUS PREMIER STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541975 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918412220 16470533

    Patients

    Seq Age Sex Outcome Treatment
    1