BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2170417 · Received July 20, 2011

    Report

    Report Number
    2134265-2011-02710
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    April 20, 2011
    Report Date
    June 21, 2011
    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 EVALUATION: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED THAT THE TIP OF THE DEVICE WAS SLIGHTLY FLARED. THIS TYPE OF DAMAGE IS CONSISTENT WITH GUIDEWIRE MOVEMENT DURING ATTEMPTS TO CROSS THE LESION. THE STENT WAS DAMAGED ALONG ITS ENTIRE LENGTH. THE OUTER DIAMETER OF THE STENT DAMAGE MEASURED APPROXIMATELY 1.45 MM. THE HYPOTUBE WAS KINKED ALONG ITS ENTIRE LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH SOME RESISTANCE. CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE LUMEN, INDICATING THAT THE DEVICE WAS PREPPED FOR USE. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE DEVICE FAILED TO CROSS THE LESION. THE 90% STENOTIC LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN PREDILATED THE LESION WITH A 2.5X20MM NON-BSC BALLOON. THEN THE PHYSICIAN ADVANCED THE 4.0X28MM PROMUS ELEMENT STENT TO THE LESION, BUT WAS UNABLE TO CROSS. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THE STENT WAS DAMAGED. THIS DEVICE IS ONLY OUS APPROVED BUT IS SIMILAR TO MARKETED 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 H7493911328400 13165286

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 2.5X20MM VOYAGER BALLOON CATHETER