BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2944163 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00261
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 7, 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 COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. 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 STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE CALCIFIED AND SEVERLY TORTUOUS RIGHT CORONARY ARTERY. THE PHYSICIAN ADVANCED THE 3.00X32MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM AND WAS NOT ABLE TO CROSS THE LESION. THE DEVICE WAS SUCCESSFULLY REMOVED AND IT WAS NOTED THAT STENT DAMAGE HAD OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48916 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918432300 15468745

    Patients

    Seq Age Sex Outcome Treatment
    1