BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ? LONG

    MDR report key: 3896447 · Received June 26, 2014

    Report

    Report Number
    2134265-2014-03565
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    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 A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: VISUAL EXAMINATION OF THE BUMPER TIP FOUND NO DAMAGE OR ISSUES WITH ITS PROFILE. 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 EXAMINATION OF THE STENT FOUND NO ISSUES WITH ITS PROFILE. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MIDSHAFT SECTION FOUND NO ISSUES WITH THEIR PROFILE. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKING ON THE HYPOTUBE SHAFT AND THE SHAFT ITSELF WAS BROKEN IN THE REGION OF THE SEVERE KINKING. THE HYPOTUBE BROKE 205MM DISTAL FROM THE STRAIN RELIEF. THE HYPOTUBE MAY HAVE BROKE DUE TO THE APPLICATION OF EXCESSIVE FORCE WHICH MAY HAVE INITIALLY KINKED THE DEVICE AND THEN RESULTED IN THE HYPOTUBE BREAKING. 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 TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. PREDILATION WAS PERFORMED WITH A 2.5X15MM UNSPECIFIED BALLOON CATHETER. A 2.50X38MM PROMUS ELEMENT ¿ LONG STENT DELIVERY SYSTEM WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE STENT DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374234 PROMUS ELEMENT ? LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338250 16576441

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR