BEUDAMED
    FDA Adverse Event Death Summary report: N

    EKOSONIC KIT 106CM 12CM TZ

    MDR report key: 18149716 · Received November 16, 2023

    Report

    Report Number
    2124215-2023-63255
    Event Type
    Death
    Date Received
    November 16, 2023
    Date of Event
    January 1, 2009
    Report Date
    November 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K213422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME - (B)(6). APA CITATION: MONTELEONE, PETER, ET AL. (2023). MODERN TREATMENT OF PULMONARY EMBOLISM (USCDT VERSUS MT): RESULTS FROM A REAL-WORLD, BIG DATA ANALYSIS (REAL-PE). JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS, 1-6. HTTPS://DOI.ORG/HTTPS://DOI.ORG/10.1016/J.JSCAI.2023.101192.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA ATTACHED LITERATURE ARTICLE THAT SEVERAL PATIENTS DIED IN HOSPITAL FOLLOWING EKOS PROCEDURES. FOR THE STUDY, THE AUTHORS REVIEWED PATIENTS TREATED FOR PULMONARY EMBOLISM WITH ULTRASOUND-ASSISTED CATHETER-DIRECTED THROMBOLYSIS (USCDT) OR MECHANICAL THROMBECTOMY (MT). FOR PATIENTS TREATED WITH USCDT, THE TREATING DEVICE WAS EKOS. PATIENTS TREATED FOR MT WERE TREATED WITH A NON-BOSTON SCIENTIFIC DEVICE. FROM THE DATA REVIEWED, BETWEEN JANUARY 2009 AND MAY 2023, 41 OUT OF THE 1577 (2.6%) PATIENTS TREATED WITH USCDT DIED IN HOSPITAL WITHIN 7 DAYS OF THE INDEX PROCEDURE. NO FURTHER DETAIL WAS PROVIDED REGARDING THE CAUSE OF DEATH FOR EACH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544645 EKOSONIC KIT 106CM 12CM TZ CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death