BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2173919 · Received July 24, 2011

    Report

    Report Number
    2134265-2011-02921
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 30, 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 MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED DISTAL STENT DAMAGE. STRUTS ON ROWS THE 1ST AND 2ND ROWS FROM THE DISTAL END WERE SLIGHTLY RAISED AND MISALIGNED. THE DISTAL END OF THE STENT WAS RESTING ON THE PROXIMAL END OF THE DISTAL MARKERBAND. THE OUTER DIAMETER (OD) OF THE DAMAGED SECTION WAS MEASURED AT 1.32MM. THE OD OF THE STENT AREA WHERE NO DAMAGE WAS PRESENT WAS MEASURED AT 1.18 MM. NO ISSUES WERE NOTED WITH THE BALLOON AND TIP SECTIONS OF THE DEVICE. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. 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 STENTING TREATMENT PROCEDURE, DIFFICULTY CROSSING OCCURRED. THE 84% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). THE LESION WAS PREDILATED AND A 3.0X16MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS ADVANCED BUT WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, PRODUCT 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 H7493911316300 13190509

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR