BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3875321 · Received June 16, 2014

    Report

    Report Number
    2134265-2014-03278
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 19, 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 EXAMINATION OF THE CRIMPED STENT FOUND STENT STRUTS ON THE DISTAL PORTION AND THE PROXIMAL END OF THE CRIMPED STENT WERE LIKELY TO BE PARTIALLY EXPANDED. THE STENT STRUTS AT THESE LOCATIONS WERE FOUND TO BE DAMAGED AND DISTORTED. FROM ANALYSIS IT WOULD APPEAR LIKELY THAT THE BALLOON WOULD HAVE BEEN SUBJECT TO SOME POSITIVE PRESSURE SO AS TO HAVE THE STENT PARTIALLY EXPANDED IN THESE LOCATIONS. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE HYPOTUBE PROFILE AND THE SHAFT POLYMER EXTRUSION PROFILE. 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 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA). PREDILATATION WAS PERFORMED USING AN UNSPECIFIED BALLOON CATHETER. ADDITIONAL DILATATION WAS PERFORMED USING AN UNSPECIFIED CUTTING BALLOON. A 3.50X28MM PROMUS ELEMENT¿ PLUS STENT WAS SELECTED AND ADVANCED HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE TARGET LESION DUE TO CALCIFICATION. AFTER SEVERAL ATTEMPTS TO CROSS THE LESION, IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS LIFTED. THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA). PREDILATATION WAS PERFORMED USING AN UNSPECIFIED BALLOON CATHETER. ADDITIONAL DILATATION WAS PERFORMED USING AN UNSPECIFIED CUTTING BALLOON. A 3.50X28MM PROMUS ELEMENT PLUS STENT WAS SELECTED AND ADVANCED HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE TARGET LESION DUE TO CALCIFICATION. AFTER SEVERAL ATTEMPTS TO CROSS THE LESION, IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS LIFTED. THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352514 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918428350 16020321

    Patients

    Seq Age Sex Outcome Treatment
    1