BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1832515 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-03976
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 24, 2010
    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 IDENTIFIED STENT DAMAGE. ONE ROW IN MIDDLE OF THE STENT HAS 1 STRUT RAISED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. 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. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED NO KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. 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

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE DEVICE WAS UNABLE TO CROSS THE LESION. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A 2.0X15MM MAVERICK BALLOON AND THEN THE 3.00X20MM PROMUS ELEMENT STENT WAS ADVANCED TO THE LAD BUT WAS UNABLE TO CROSS THE LESION. THE LESION WAS REDILATED AND ANOTHER OF THE SAME DEVICE WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED WITH THE PATIENT'S STATUS LISTED AS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE. THIS PRODUCT IS ONLY OUS APPROVED BUT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320300 0013375996

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 2.0X15MM MAVERICK BALLOON CATHETER