BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2962389 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00644
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    October 25, 2012
    Report Date
    January 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    (B)(4). (B)(6) 2012 - THE DE NOVO, CONCENTRIC TARGET LESION WAS LOCATED AT THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN PLACED A 2.75 X 24MM PROMUS ELEMENT PLUS STENT AT 14 ATMS. HOWEVER, A DISSECTION OCCURRED IN THE 1ST DIAGONAL BRANCH OF THE LAD DURING THE PROCEDURE. THE DISSECTION WAS RESOLVED AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65514 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324270

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention