BEUDAMED
    FDA Adverse Event Death Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 8175046 · Received December 18, 2018

    Report

    Report Number
    3001627457-2018-00039
    Event Type
    Death
    Date Received
    December 18, 2018
    Report Date
    November 26, 2018
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K140151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LIMITED INFORMATION WAS PUBLISHED REGARDING THE RETROSPECTIVE IN-HOSPITAL DEATH DUE TO MASSIVE HEMOTHORAX. NO "PAITENT" OR PROCEDURE SPECIFIC INFORMATION WAS PUBLISHED. THE MASSIVE HEMOTHORAX WAS IDENTIFIED DURING AUTOPSY. BASED ON THE INFORMATION AVAILABLE, THE CAUSE AND RELATIONSHIP TO THE EKOS DEVICE AND PROCEDURE IS UNKNOWN. NO ADDITIONAL INFORMATION IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION CONTAINING SAFETY EVENTS WAS REVIEWED ON 26 NOV 2018: TITLE: ULTRASOUND-ASSISTED CATHETER-DIRECTED THROMBOLYSIS COMPARED WITH ANTICOAGULATION ALONE FOR TREATMENT OF INTERMEDIATE-RISK PULMONARY EMBOLISM AUTHORS: ANDREW J. SCHISSLER, ROBERT J. GYLNN, PIOTR S. SOBIESZCZYK AND AARON B. WAXMAN FACILITY: (B)(6) HOSPITAL/(B)(6) MEDICAL SCHOOL. THIS STUDY SOUGHT TO EVALUATE ANY LASTING ADVANTAGE OF UACDT (ULTRASOUND-ASSISTED CATHETER-DIRECTED THROMBOLYSIS) ON MORTALITY AND RESOLUTION OF RV DYSFUNCTION IN INTERMEDIATE-RISK PE AT A LARGE ACADEMIC MEDICAL CENTER. ADULTS AGED <86 YEARS ADMITTED WITH INTERMEDIATE RISK PE FROM 2011 TO 2016 WERE RETROSPECTIVELY IDENTIFIED. OUTCOMES INCLUDING LENGTH OF STAY (LOS), BLEEDING COMPLICATIONS, RESOLUTION OF RV DYSFUNCTION, AND MORTALITY WERE COMPARED BETWEEN PATIENTS WHO RECEIVED UACDT AND THOSE MANAGED WITH ANTICOAGULATION ALONE. A TOTAL OF 104 PATIENTS WERE INCLUDED IN THE ANALYSIS, 65 OF WHOM RECEIVED UACDT. ONE "PAITENT" DIED BEFORE DISCHARGE IN THE UACDT COHORT DUE TO MASSIVE HEMOTHORAX CONFIRMED ON AUTOPSY. ALL OTHER SAFETY EVENTS REPORTED ARE CONSIDERED TO BE UNRELATED TO EKOS. THE RELATIONSHIP BETWEEN THE FATAL MASSIVE HEMOTHORAX AND THE EKOS DEVICE/PROCEDURE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015177 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death