BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1834605 · Received September 15, 2010

    Report

    Report Number
    2134265-2010-03972
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    July 14, 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

    (B)(4): A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED PROXIMAL STENT DAMAGE. ROWS 1-2 HAD STRUTS RAISED DISTALLY. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, CROSSING DIFFICULTIES OCCURRED. THE 75% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED MID TO DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED USING A 2.5X15MM MAVERICK BALLOON. THE 4.0X20MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION BUT COULD NOT CROSS THE LESION. BALLOONING WAS DONE AGAIN USING AN UNKNOWN BALLOON AND THE CASE WAS COMPLETED USING A 3.5X20MM PROMUS ELEMENT SDS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    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 H7493911320400 13098067

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 2.5 X 15MM MAVERICK BALLOON