BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3923689 · Received July 9, 2014

    Report

    Report Number
    2134265-2014-03928
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE BUMPER TIP FOUND NO DAMAGE OR ISSUES WITH ITS PROFILE. THE BALLOON CONES PROFILES WERE ALSO REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. A VISUAL EXAMINATION OF THE STENT FOUND NO ISSUES WITH ITS PROFILE. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MIDSHAFT SECTIONS FOUND NO ISSUES WITH THEIR PROFILE. A VISUAL AND TACTILE EXAMINATION FOUND SEVERE KINKING ON THE HYPOTUBE SHAFT AND THE SHAFT ITSELF WAS BROKEN IN THE REGION OF THE SEVERE KINKING. THE HYPO-TUBE BROKE 933MM DISTAL FROM STRAIN RELIEF. 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

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES WAS ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 28 X 3.50 PROMUS PREMIER DRUG ELUTING STENT WAS SELECTED FOR USE AND ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399713 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925128350 16685613

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR