BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1852557 · Received October 4, 2010

    Report

    Report Number
    2134265-2010-04318
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 22, 2010
    Report Date
    September 14, 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 REVEALED THAT THE STENT MOVED DISTALLY ON THE BALLOON SO THAT THE DISTAL EDGE OF THE STENT WAS OVER THE TIP OF THE STENT DELIVERY SYSTEM. THE MIDDLE AND DISTAL SECTIONS OF THE STENT WERE STRETCHED DISTALLY AND MISALIGNED. THE STRUTS IN THE MIDDLE OF THE STENT WERE STRETCHED AND THE STRUTS IN THE PROXIMAL SECTION OF THE STENT WERE MISALIGNED. THERE WAS NO DAMAGE ALONG THE SHAFT OF THE DEVICE. 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 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 AND/OR PROCEDURAL FACTORS. (B)(4)

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE 90% STENOTIC LESION WAS LOCATED IN THE SEVERELY TORTUOUS MID RIGHT CORONARY ARTERY. THE PHYSICIAN PREDILATED THE LESION WITH A 2.5X20MM MAVERICK BALLOON AND THEN ADVANCED A 3.0X28MM PROMUS ELEMENT STENT TO THE LESION BUT WAS UNABLE TO CROSS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THERE WAS STENT DAMAGE. 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 H7493911328300 13130451

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 2.5X20MM MAVERICK BALLOON CATHETER