BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3881042 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03356
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 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 COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE STENT WAS DAMAGED AT ITS DISTAL END. THE THIRD AND FIFTH MOST DISTAL ROWS OF STRUTS WERE RAISED AND MISALIGNED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ATTEMPTS TO ADVANCE THE DEVICE. THE TIP OD WAS MEASURED TO BE 0.0270IN USING A DIGITAL SNAP GAUGE WHICH IS WITHIN SPECIFICATION. NO ISSUES WERE NOTED WITH THE BALLOON OF THE DEVICE. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. SOLIDIFIED CONTRAST MEDIUM WAS VISIBLE IN THE INFLATION LUMEN INDICATING THE DEVICE WAS PREPPED FOR USE. NO KINKS OR OTHER DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT 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 STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED DISTAL LEFT CIRCUMFLEX. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON CATHETER. A 3.50X20MM PROMUS ELEMENT PLUS STENT WAS SELECTED; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION DUE TO CALCIFICATION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE EDGE OF THE STENT WAS FOUND LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    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 MODERATELY CALCIFIED DISTAL LEFT CIRCUMFLEX. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON CATHETER. A 3.50X20MM PROMUS ELEMENT PLUS STENT WAS SELECTED HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION DUE TO CALCIFICATION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE EDGE OF THE STENT WAS FOUND LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357401 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918420350 16470532

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: SION BLUE ASAHI| INFLATION DEVICE: EVEREST| GUIDING CATHETER: 6F MACH1 BSJ