BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3231166 · Received July 17, 2013

    Report

    Report Number
    2134265-2013-04746
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    April 15, 2013
    Report Date
    June 20, 2013
    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. (B)(4). DEVICE EVALUATED BY MANUFACTURER - EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE HYOPTUBE WAS BROKEN AT APPROXIMATELY 49MM DISTAL TO THE STRAIN RELIEF. SEVERAL OTHER KINKS WERE NOTED ALONG THE LENGTH OF THE HYPOTUBE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE STENT NOTED THAT TWO OF THE STENT STRUTS HAD LIFTED AT APPROXIMATELY 23MM PROXIMAL TO ITS DISTAL END. EXAMINATION OF THE FOLDED BALLOON MATERIAL AND THE DISTAL TIP SECTION FOUND NO ISSUES WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. 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 ANALYSIS COMPLETED (B)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A SHAFT BEND OCCURRED. THE 88% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS DILATED WITH A 1.5X15MM MAVERICK BALLOON. THE 2.5X38MM PROMUS ELEMENT STENT WAS ADVANCED HOWEVER WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5X38MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE, HOWEVER RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE AND A SHAFT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330981 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918438250 15797488

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR