BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2944428 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00351
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: DEVICE ANALYSIS DETERMINED THAT THE CONDITION ON THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED STENT DAMAGE. THE STRUTS ON THE FIRST TWO ROWS ON THE PROXIMAL END OF THE STENT WERE BUNCHED TOGETHER AND SOME OF THE STRUTS WERE RAISED UP. THE STRUTS ON THE FIRST ROW ON THE DISTAL END OF THE STENT WERE MISALIGNED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. THE BALLOON AND THE TIP 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 ANY POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A STENT WAS DAMAGED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED POSTEROLATERAL OF THE LEFT CIRCUMFLEX ARTERY. THE 2.25X20MM PROMUS ELEMENT PLUS WAS UNABLE TO CROSS THE LESION. AFTER THE STENT WAS REMOVED FROM THE PATIENT IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49157 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918420220 0015662081

    Patients

    Seq Age Sex Outcome Treatment
    1