BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT

    MDR report key: 18335801 · Received December 14, 2023

    Report

    Report Number
    MW5149291
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    April 23, 2023
    Report Date
    December 12, 2023
    Manufacturer
    UNK
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SUFFERED NSTEMI FROM THROMBUS IN STENT AFTER SOME MONTHS OF TAKING PRESCRIPTION LOVAZA 4G/DAY. MAY OR MAY NOT BE RELATED TO LOVAZ BUT IMO DEFINITELY WORTH INVESTIGATING IN AS MUCH AS STUDIES IN RABBITS REPORT HIGH EPA RESULTS IN EXACERBATED, FOAM CELL AGGREGATION AT POINTS OF ENDOTHELIAL INJURY. IN MY CASE, I HAD STENTS INSIDE A L CIRCUMFLEX, LONG SVG BYPASS. SVG LASTED 17 YEARS AND THEN WAS STENTED IN 2020. NSTEMI HAPPENED IN 2023. TREATED AT (B)(6) HOSPITAL, (B)(6) CANNOT SAY FOR CERTAIN THE LOVAZA PROMPTED THE THROMBUS BUT I WONDER IF IT CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98204 STENT STENT, CORONARY MAF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Hospitalization LOVAZA| REPATHA