BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2983594 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01198
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. 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 CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. USING AN UNKNOWN ACCESS, THE SEVERELY TORTUOUS AND CALCIFIED LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. THE 2.50MM X 16MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS ADVANCED BUT UNABLE TO CROSS THE LESION. UPON REMOVAL OF THE DEVICE, STENT DAMAGE AND "FLARING" WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85657 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316250 15246288

    Patients

    Seq Age Sex Outcome Treatment
    1