BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIEVER24

    MDR report key: 10577169 · Received September 23, 2020

    Report

    Report Number
    3011525976-2020-00020
    Event Type
    Death
    Date Received
    September 23, 2020
    Date of Event
    August 28, 2020
    Report Date
    September 23, 2020
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007185
    PMA / PMN Number
    K191710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE DEVICE MANUFACTURING LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. THE RELATIONSHIP BETWEEN THE TRIEVER24 AND THE EVENT IS NOT KNOWN AT THIS TIME; ADDITIONAL INFORMATION IS BEING REQUESTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A POTENTIAL QUALITY ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. DEATH IS LISTED IN THE DEVICE LABELING AS A POTENTIAL COMPLICATIONS / ADVERSE EVENTS. (B)(4).

    Description of Event or Problem · 1

    A (B)(6)-YEAR-OLD FEMALE PATIENT WITH A BILATERAL SUBMASSIVE PULMONARY EMBOLISM (PE) PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH AND CHEST PAIN. ON (B)(6) 2020, THE INARI MEDICAL TRIEVER24 (T24) WAS USED TO ATTEMPT TO TREAT THE PE. AT THE START OF THE CASE, THE PATIENT WAS NORMOTENSIVE AND BREATHING ROOM AIR. LOCAL ANESTHESIA WITH LIGHT SEDATION WAS ADMINISTERED AND ULTRASOUND WAS USED TO GUIDE ACCESS VIA THE RIGHT COMMON FEMORAL VEIN. A 5 FR SHEATH WAS PLACED AND A VENOGRAM OF THE INFERIOR VENA CAVA (IVC) REVEALED A CLOT ABOVE THE RENAL VEINS. THE 5 FR SHEATH WAS EXCHANGED FOR A GORE DRYSEAL SHEATH AFTER THE ACCESS SITE WAS DILATED, THEN THE T24 WAS ADVANCED TO THE IVC. ONE ASPIRATION SUCCESSFULLY REMOVED THE ENTIRETY OF THE IVC CLOT. THE T24 WAS REMOVED AND AN ANGLED PIGTAIL CATHETER WAS INSERTED TO OBTAIN PRESSURE MEASUREMENTS AND IMAGES OF THE RIGHT PULMONARY ARTERY (PA). A GUIDEWIRE WAS ADVANCED TO THE BASAL TRUNK OF THE RIGHT LOWER LOBE AND EXCHANGED FOR A BOSTON SCIENTIFIC AMPLATZ SUPER STIFF GUIDEWIRE. THE T24 WAS SLOWLY ADVANCED FROM THE IVC ACROSS THE HEART TO THE MAIN PA. AT THIS POINT, THE INARI REPRESENTATIVE NOTICED THE AMPLATZ GUIDEWIRE WAS UNDULATING; AFTER ASCERTAINING THAT THE PHYSICIAN USED A 7 CM TIP WIRE, IT WAS EXCHANGED IT FOR A 1 CM TIP WIRE. DISTAL PURCHASE WAS REGAINED IN THE BASAL TRUNK AND THE T24 WAS ADVANCED WITHOUT INCIDENT INTO THE PROXIMAL RIGHT PA. ONE ASPIRATION YIELDED A SIGNIFICANT AMOUNT OF CLOT. THE DEVICE WAS PULLED BACK AND USED TO PERFORM A SECOND ASPIRATION, WHICH YIELDED MORE CLOT. THE PATIENT REPORTED EXPERIENCING PAIN AS THE T24 WAS MANEUVERED, PARTICULARLY DURING ASPIRATIONS. ADDITIONAL LIGHT SEDATION WAS ORDERED TO BE ADMINISTERED. AFTER THE SECOND ASPIRATION IN THE RIGHT PA, THE PATIENT ARRESTED. AS CHEST COMPRESSIONS WERE INITIATED AND CONDUCTED OVER THE NEXT HOUR, THE PATIENT WAS RESUSCITATED AND ADDITIONAL INARI PERSONNEL WERE CONTACTED. A CARDIOLOGIST CONDUCTED A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WHICH SHOWED THE HEART VALVES WERE ALL FUNCTIONING NORMALLY AND THERE WERE NO PERFORATIONS, RUPTURES, OR DISSECTIONS NOTED IN THE HEART, MAIN, OR BILATERAL PULMONARY ARTERIES AND NO EVIDENCE OF CARDIAC TAMPONADE. THROMBOLYTIC MEDICATION WAS ADMINISTERED SYSTEMICALLY AND LOCALLY (INJECTED DIRECTLY INTO THE PAS). THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT, WHERE SHE EXPIRED AN HOUR LATER. NO IMAGING WAS PERFORMED AFTER THE SECOND CLOT ASPIRATION SO THERE IS NO INSIGHT ON THE PATIENT'S CLOTTING/ARTERIAL STATUS PRIOR TO HER ARREST. THE CAUSE OF DEATH IS NOT KNOWN AT THIS TIME; ADDITIONAL INFORMATION IS BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038503 TRIEVER24 EMBOLECTOMY CATHETER QEW INARI MEDICAL, INC. 22-101 20050006 00850291007185

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death| H| L| R