BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3963685 · Received July 29, 2014

    Report

    Report Number
    2134265-2014-04377
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 3, 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

    DATE OF BIRTH: 1943. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKING ON THE HYPOTUBE SHAFT AND THE SHAFT ITSELF WAS BROKEN IN THE REGION OF A SEVERE KINK. THE HYPOTUBE BROKE 311MM 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. 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. THE BI-COMPONENT BOND SHOWED NO SIGNS OF DAMAGE OR STRAIN. 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 SHAFT BREAK OCCURRED. THE >70% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND SEVERELY TORTUOUS CIRCUMFLEX ARTERY. A 2.75X16MM PROMUS ELEMENT ¿DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE TARGET LESION. UPON ADVANCING, IT WAS NOTICED THAT THE DISTAL SHAFT BROKE. THE DEVICE WAS PULLED BACK OUT COMPLETELY WITH NO ADDITIONAL PROCEDURES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE >70% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND SEVERELY TORTUOUS CIRCUMFLEX ARTERY. A 2.75X16MM PROMUS ELEMENT DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE TARGET LESION. UPON ADVANCING, IT WAS NOTICED THAT THE DISTAL SHAFT BROKE. THE DEVICE WAS PULLED BACK OUT COMPLETELY WITH NO ADDITIONAL PROCEDURES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442269 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316270 0016115250

    Patients

    Seq Age Sex Outcome Treatment
    1