BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2904264 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08246
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    September 26, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    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 MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE NOTED STENT DAMAGE. A STRUT IN THE MIDDLE OF THE STENT WAS RAISED AND MISALIGNED. A VISUAL AND MICROSCOPIC EXAMINATION ALSO IDENTIFIED KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. 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

    SAME CASE AS MFR ID # 2134265-2012-06413. REPORTABLE BASED ON ANALYSIS COMPLETED (B)(6) 2012. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.0X38MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE LAD RESULTING IN SMOOTH TIMI FLOW. HOWEVER IT WAS NOTED THAT PLAQUE SHIFTED INTO THE 2ND DIAGONAL ARTERY AND WAS BLOCKING FLOW. SEVERAL ATTEMPTS WERE MADE TO CROSS THE 2.5X12MM PROMUS ELEMENT STENT BUT THE PHYSICIAN WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH DILATION OF A 1.5X15MM MAVERICK BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. HOWEVER; RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12776 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312250 14362308

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR STENT: 3.0X38MM PROMUS ELEMENT