BEUDAMED
    FDA Adverse Event Death Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 8708218 · Received June 18, 2019

    Report

    Report Number
    3001627457-2019-00019
    Event Type
    Death
    Date Received
    June 18, 2019
    Report Date
    May 22, 2019
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K140151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO DEVICE MALFUNCTION OR PROCEDURAL ISSUES REPORTED. EIGHTEEN PATIENTS AFFECTED BY HIGH-RISK ACUTE PULMONARY EMBOLISM (APE) OR INTERMEDIATE-HIGH-RISK APE WERE INCLUDED. THE PRIMARY SAFETY END-POINT WAS THE OCCURRENCE OF BLEEDING WITHIN 72 HOURS AFTER THE PROCEDURE. FIVE BLEEDING EVENTS OCCURRED: ONE FATAL AND FOUR MODERATES; THREE OUT OF THEM LED TO THE ACCESS SITE HEMATOMA, TWO DUE TO PRE-EXISTING ACTIVE BLEEDING. THE AUTHORS CONCLUDED THAT EKOS IS AN EFFECTIVE TOOL TO TREAT PATIENTS WITH TO FIBRINOLYSIS. IT IS A RELATIVELY SAFE THERAPY CONSIDERING THE CRITICAL CONDITIONS AND HIGH BLEEDING RISK OF THE RECEIVING POPULATION. THESE SAES REPORTED IN THE ARTICLE ARE CONSIDERED TO BE PROCEDURE-RELATED AND NOT RELATED TO THE EKOS DEVICE. THESE SAES WERE NOT REPORTED TO THE MANUFACTURER AT THE TIME OF THE EVENT NO ADDITIONAL INFORMATION WILL BE AVAILABLE.

    Description of Event or Problem · 1

    THIS WAS A RETROSPECTIVE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE EKOSONIC ENDOVASCULAR SYSTEM (EKOS) IN PATIENTS WITH ACUTE PULMONARY EMBOLISM (APE) AT HIGH OR INTERMEDIATE-HIGH RISK AND CONTRAINDICATION TO SYSTEMIC FIBRINOLYSIS. FEMORAL ACCESS WAS USED IN 11 PATIENTS AND 7 PATIENTS RECEIVED A JUGULAR APPROACH. 13 PATIENTS HAD UNILATERAL AND 5 HAD BILATERAL TREATMENT. AN OPTIMAL PLACEMENT OF THE CATHETERS WAS ACHIEVED IN ALL PATIENTS. ALL CATHETERS WERE POSITIONED INTO THE PROXIMAL LOWER LOBE PULMONARY ARTERY BRANCH. AFTER THE CATHETERIZATION, ALL PATIENTS WERE MONITORED IN THE CARDIAC ICU OVER THE ENTIRE INFUSION PERIOD (MEAN INFUSION TIME 17 H; RANGE 10-24 H). LOW-DOSE T-PA WAS USED WITH RADIAL ULTRASOUND ENERGY (MEAN TOTAL DOSE 20 + 1.18 MG) AT AN INFUSION RATE (PER CATHETER) OF 0.75-1.6 MG/H, WITH A SIMULTANEOUS ADMINISTRATION OF A SALINE COOLANT AT 35 ML/H. IN CASE OF BILATERAL PULMONARY EMBOLISM, TWO IDDC (ONE FOR EACH SIDE) WERE POSITIONED, REDUCING BOTH THE INFUSION RATE AND TREATMENT DURATION (10-13 H), RESULTING IN A TOTAL RT-PA DOSE OF 20MG FOR EACH PATIENT. ALL PATIENTS RECEIVED CONTINUOUS INTRAVENOUS UNFRACTIONATED HEPARIN BEFORE, DURING AND AFTER THE PROCEDURE. ORAL ANTICOAGULANT THERAPY WAS STARTED BETWEEN 5 DAYS AFTER THE PROCEDURE TO THE DISCHARGE. THE FOLLOWING SAFETY END-PONTS WERE DISCUSSED IN THE ARTICLE: A (B)(6) PATIENT EXPERIENCED FATAL BLEEDING DUE TO A LARGE HAEMATOMA OF THE JUGULAR VEIN ACCESS. SHE WAS AFFECTED BY ADVANCED BREAST CANCER AND DIED BECAUSE OF ACUTE RESPIRATORY ARREST 12 HOURS AFTER THE PROCEDURE. FOUR PATIENTS REPORTED MODERATE BLEEDING. TWO OUT OF THEM HAD HAEMATOMA OF THE ACCESS SITE AND THE REMAINING TWO HAD PRE-EXISTING ACTIVE BLEEDING WITH LOW HAEMOGLOBIN LEVELS AND NEED FOR TRANSFUSIONS EVEN BEFORE THE PROCEDURE. AN (B)(6) PATIENT ADMITTED ON CARDIOGENIC SHOCK (PESI SCORE 139) DIED FROM MULTIPLE ORGAN FAILURE 12 DAYS AFTER THE PROCEDURE. NO OTHER PATIENTS DIED AFTER THE DISCHARGE WITHIN 30-DAY AND 90-DAY FOLLOW-UP. ADDITIONALLY, EIGHT PATIENTS HAD SUPRAVENTRICULAR ARRHYTHMIAS (I.E. ATRIAL FIBRILLATION OR PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA) AND TWO PATIENTS EXPERIENCED NON-SUSTAINED VENTRICULAR TACHYCARDIA DURING EKOS. THERE WERE NO DEVICE OR PROCEDURAL ISSUES REPORTED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502241 EKOSONIC ENDOVASCULAR CATHETER EKOSONIC ENDOVASCULAR CATHETER KRA EKOS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| O