BEUDAMED
    FDA Adverse Event Death Summary report: N

    EKOSONIC KIT 106CM 12CM TZ

    MDR report key: 10079521 · Received May 21, 2020

    Report

    Report Number
    2134265-2020-06842
    Event Type
    Death
    Date Received
    May 21, 2020
    Date of Event
    April 1, 2020
    Report Date
    May 21, 2020
    Manufacturer
    BTG BOTHELL
    Product Code
    KRA
    PMA / PMN Number
    K182324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BEYER, S. E., SANAFELT, C., PINTO, D. S., WEINSTEIN, J. L., ARONOW, H. D., WEINBERG, I., CARROLL, B. J. (2020). UTILIZATION AND OUTCOMES OF THROMBOLYTIC. UTILIZATION AND OUTCOMES OF THROMBOLYTIC, CHEST(157), 645-653.

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE, BLEEDING REQUIRING TRANSFUSION, SURGICAL THROMBECTOMY, AND IN HOSPITAL MORTALITY OCCURRED. THE PURPOSE OF THE ARTICLE IS TO EXAMINE PRACTICE PATTERNS OF SYSTEMIC THROMBOLYSIS AND CATHETER-DIRECTED THROMBOLYSIS (CDT) AND TO COMPARE OUTCOMES FOLLOWING CDT WITH ULTRASOUND FACILITATION (CDT-ULTRASOUND) AND CDT ALONE. ALTHOUGH VARIOUS FORMS OF CATHETER-DIRECTED THROMBOLYSIS (CDT) EXIST, THE BEST STUDIED AND ONLY DEVICE APPROVED BY THE US FOOD AND DRUG ADMINISTRATION FOR THE MANAGEMENT OF PE IS THE EKOSONIC ENDOVASCULAR SYSTEM (EKOS). ALTHOUGH THERE WERE CLEAR DIFFERENCES BETWEEN PATIENTS RECEIVING SYSTEMIC THROMBOLYSIS AND CDT, THERE WERE MINIMAL DIFFERENCES IN BASELINE PATIENT CHARACTERISTICS AND COMORBIDITIES BETWEEN CDT-ULTRASOUND AND CDT ALONE. IN ADDITION, ASSOCIATED HIGH-RISK FEATURES OF ACUTE PE, INCLUDING MECHANICAL VENTILATION, HYPOTENSION, SHOCK, AND VASOPRESSOR UTILIZATION, WERE SIMILAR. WE FOUND NO DIFFERENCES IN BLEEDING, IN-HOSPITAL MORTALITY, OR READMISSIONS BETWEEN CDT-ULTRASOUND AND CDT ALONE. NOTABLY, THE RATE OF MAJOR BLEEDING WAS SIMILAR TO THAT SEEN IN THE SEATTLE II TRIAL. RATES OF INTRACRANIAL HEMORRHAGE WERE LOW, AND THEY OCCURRED IN 0.6% OF PATIENTS RECEIVING CDT ULTRASOUND. NO FURTHER INFORMATION IS KNOWN REGARDING THE PATIENT EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543314 EKOSONIC KIT 106CM 12CM TZ CATHETER, CONTINUOUS FLUSH KRA BTG BOTHELL

    Patients

    Seq Age Sex Outcome Treatment
    1