BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3063047 · Received April 17, 2013

    Report

    Report Number
    2134265-2013-02285
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT. THE DEVICE WAS NOT RETURNED. 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)(6) CLINICAL STUDY. IT WAS REPORTED THAT POST A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED SLOW FLOW. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX WITH 90% STENOSIS, A LENGTH OF 6 MM, AND A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 3.0 X 8 MM PROMUS ELEMENT PLUS STUDY STENT WITH 0% RESIDUAL STENOSIS. POST PROCEDURE, AN EVENT OF "SLOW FLOW POST STENT DEPLOYMENT" OCCURRED. THE EVENT WAS TREATED WITH MEDICATION. THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166141 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911408300

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention