BEUDAMED
    FDA Adverse Event Death Summary report: N

    EKOSONIC KIT 106CM 12CM TZ

    MDR report key: 10079233 · Received May 21, 2020

    Report

    Report Number
    2134265-2020-06839
    Event Type
    Death
    Date Received
    May 21, 2020
    Date of Event
    December 26, 2019
    Report Date
    May 21, 2020
    Manufacturer
    BTG BOTHELL
    Product Code
    KRA
    PMA / PMN Number
    K182324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STEWART, LAUREN, K., (2020) "EFFECT OF METABOLIC SYNDROME ON MEAN PULMONARY ARTERIAL PRESSURES IN PATIENTS WITH ACUTE PULMONARY EMBOLISM TREATED WITH CATHETER-DIRECTED THROMBOLYSIS" INTERNATIONAL JOURNAL OF CARDIOLOGY 302 PP.138-142.

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THERE WERE 9 DEATHS ACROSS ALL PATIENTS. THE OBJECTIVE WAS TO MEASURE THE PREVALENCE OF METABOLIC SYNDROME (METS) IN PATIENTS WITH ACUTE PE RECEIVING CATHETER-DIRECTED THROMBOLYSIS (CDT) EKOS AND TO INVESTIGATE ITS EFFECT ON MEAN PULMONARY ARTERIAL PRESSURE AND OVERALL TREATMENT SUCCESS. THE PRESENCE OR ABSENCE OF METS COMPONENTS WERE EXTRACTED BASED ON THE FOLLOWING CRITERIA: BODY MASS INDEX (BMI) N30 KG/M2; DIAGNOSED HYPERTENSION: DIABETES MELLITUS (INCLUDING HBA1C N6.5) AND; 4. DYSLIPIDEMIA (INCLUDING TRIGLYCERIDES N150 MG/DL OR HIGH-DENSITY LIPOPROTEIN B40 MG/DL). THERE WERE 9 DEATHS ACROSS ALL PATIENTS (7%). THE MORTALITY RATE STRATIFIED BY NUMBER OF METS CRITERIA WAS AS FOLLOWS: 10% IN THOSE WITH 0 COMPONENTS, 3WITH 1 COMPONENT, 6WITH 2 COMPONENTS, 6% WITH 3 COMPONENTS AND 18% WITH ALL 4 COMPONENTS. CAUSE OF DEATHS ARE UNKNOWN AS DEVICE, PROCEDURE RELATIONSHIP WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543771 EKOSONIC KIT 106CM 12CM TZ CATHETER, CONTINUOUS FLUSH KRA BTG BOTHELL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death