BEUDAMED
    FDA Adverse Event Death Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 7425301 · Received April 12, 2018

    Report

    Report Number
    3001627457-2018-00013
    Event Type
    Death
    Date Received
    April 12, 2018
    Report Date
    March 14, 2018
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K140151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF DEATH FOR THE SIX INTERMEDIATE-HIGH RISK AND HIGH RISK PATIENTS WAS NOT REPORTED IN THE POSTER. BASED ON THE REPORTED INFORMATION INCLUDING THE STATEMENT THAT NO PE-RELATED EVENTS WERE NOTED DURING POST-DISCHARGE MEDIAN FOLLOW UP PERIOD, IT LEADS THE REVIEWER TO BELIEVE THAT THE 6 IN-HOSPITAL DEATHS WERE RELATED TO THE PULMONARY EMBOLISM AND NOT RELATED TO THE EKOS DEVICE. WHILE THE PATIENT DEATHS REPORTED ARE UNLIKELY RELATED TO EKOS, THE RELATIONSHIP BETWEEN THE PATIENT DEATHS AND THE EKOS DEVICE COULD NOT BE DETERMINED. NO DEVICE MALFUNCTIONS WERE REPORTED. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE CORRESPONDING AUTHOR FOR ADDITIONAL INFORMATION. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A POSTER TITLED 'A TERTIARY CENTRE EXPERIENCE ON ULTRASOUND-FACILITATED THROMBOLYSIS IN PATIENTS WITH PULMONARY EMBOLISM AT HIGH-RISK OR INTERMEDIATE-HIGH-RISK' PRESENTED THE RETROSPECTIVE ANALYSIS OF 125 PATIENTS AT A SINGLE-CENTER IN TURKEY. THIS POSTER WAS PRESENTED AT THE 2018 ACC (AMERICAN COLLEGE OF CARDIOLOGY) MEETING. SIX IN-HOSPITAL DEATHS (4.8%) WERE REPORTED. NO PE-RELATED EVENTS WERE NOTED DURING POST-DISCHARGE MEDIAN FOLLOW UP PERIOD OF 21.8 MONTHS (1 - 26, 5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269773 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death