BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2160109 · Received July 13, 2011

    Report

    Report Number
    2134265-2011-02871
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 28, 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 COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED DISTAL STENT DAMAGE. STRUTS WERE RAISED AND MISALIGNED ON THE 2ND AND 3RD ROWS FROM THE DISTAL END OF THE STENT. THE OUTER DIAMETER (OD) OF THE DAMAGED SECTION WAS MEASURED AT 1.64MM. THE STENT MOVED DISTALLY ON THE BALLOON AND REMAINED RESTING ON THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. NO ISSUES WERE NOTED WITH THE BALLOON AND TIP SECTIONS OF THE DEVICE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE 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 ANALYSIS COMPLETED ON (B)(6) 2011 IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, CROSSING DIFFICULTIES OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY. THE TARGET LESION WAS PRE-DILATED WITH ANOTHER MANUFACTURERS' 2.5X20MM BALLOON DILATATION CATHETER. THE 4.00X24MM PROMUS ELEMENT STENT WAS ADVANCED BUT FAILED TO CROSS THE TARGET LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURERS DRUG ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED 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 H7493911324400 13176618

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR VOYAGER 2.5X20MM BALLOON CATHETER