BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2221217 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03854
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    June 24, 2011
    Report Date
    August 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH DISTAL STENT DAMAGE. STENT STRUTS FROM THE MOST DISTAL ROW WERE BENT OUTWARDS DISTALLY. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. THE TIP AND BALLOON 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. IT WAS NOTED THAT THE DISTAL INNER WAS KINKED AT 43 MM PROXIMAL TO THE DISTAL TIP. THIS TYPE OF DAMAGE POTENTIALLY WAS CAUSED BY EXCESSIVE FORCE BEING APPLIED DURING GUIDEWIRE REMOVAL. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE GUIDEWIRE LUMEN WITH NO RESTRICTIONS NOTED. 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 THE ANALYSIS COMPLETED (B)(6) 2011 IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE 2.5X20MM PROMUS ELEMENT STENT WOULD NOT CROSS THE LESION. VASCULAR ACCESS WAS GAINED VIA THE RADIAL ARTERY. THE 90% STENOSED, 2.5X15MM, ECCENTRIC AND PROGRESSIVE LESION BEING TREATED WAS LOCATED IN THE MILDLY TORTUOUS AND NON CALCIFIED OBTUSE MARGINAL (OM) ARTERY. THE LESION WAS PRE-DILATED WITH AN UNKNOWN BALLOON. THE PHYSICIAN ADVANCED A 2.5X24MM PROMUS ELEMENT AND ENCOUNTERED RESISTANCE ADVANCING, SEVERAL ATTEMPTS WERE MADE BUT THE DEVICE WAS NOT ABLE TO CROSS THE LESION. A 2.5X20MM PROMUS ELEMENT WAS THEN ADVANCED AND AGAIN THE DEVICE COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED 2.5X18MM NON-BSC STENT SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS STABLE. RETURNED PRODUCT ANALYSIS REVELED STENT DAMAGE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT 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 H7493911320250 14144319

    Patients

    Seq Age Sex Outcome Treatment
    1