BEUDAMED
    FDA Adverse Event Death Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 7253815 · Received February 8, 2018

    Report

    Report Number
    3001627457-2018-00005
    Event Type
    Death
    Date Received
    February 8, 2018
    Report Date
    January 10, 2018
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K140151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LIMITED INFORMATION WAS PUBLISHED IN THE ABSTRACT REVIEWED. FOLLOW UP ATTEMPTS HAVE BEEN MADE TO CONTACT THE AUTHORS, BUT TO DATE, NO RESPONSE HAS BEEN RECEIVED. DUE TO THE LIMITED INFORMATION AVAILABLE, THE PATIENT DEATHS IN THE LITERATURE ARE BEING REPORTED.

    Description of Event or Problem · 1

    DURING A LITERATURE REVIEW ON JANUARY 10, 2018, IT WAS NOTED THAT PATIENT DEATHS WERE REPORTED IN PUBLICATION: '167: OPTIMAL TIMING OF CATHETER-DIRECTED THROMBOLYSIS IN TREATMENT OF SUBMASSIVE PULMONARY EMBOLISM'. THIS IS A SINGLE CENTER, RETROSPECTIVE, COHORT STUDY OF ADULT PATIENTS WHO UNDERWENT ULTRASOUND ASSISTED CATHETER DIRECTED THROMBOLYSIS USING EKOS BETWEEN JANUARY 1, 2015 AND MARCH 31, 2017. A TOTAL OF 24 PATIENTS (12 MALE AND 12 FEMALE) WHO UNDERWENT EKOS PLACEMENT FOR SUBMASSIVE PE WERE INCLUDED.. PRIMARY OUTCOME MEASURES INCLUDED TIME TO RESOLUTION OF SUPPLEMENTAL OXYGEN REQUIREMENT, DECREASE IN HEART RATE, BLEEDING AND MORTALITY. THE SUBJECTS WERE STRATIFIED INTO 3 GROUPS: 11 (45%) PATIENTS UNDERWENT INTERVENTION IN 0-12 HOURS, 6 (25%) PATIENTS IN 12-24 HOURS AND 7 (29%) PATIENTS UNDERWENT THE CATHETER PLACEMENT 24 HOURS AFTER THE DIAGNOSIS OF PE WAS MADE. THERE WERE A TOTAL OF 3 PATIENT DEATHS REPORTED (12%), ONE IN EACH CATEGORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98897 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death