BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIEVER24

    MDR report key: 19843047 · Received July 26, 2024

    Report

    Report Number
    3020347218-2024-00033
    Event Type
    Death
    Date Received
    July 26, 2024
    Date of Event
    June 28, 2024
    Report Date
    July 26, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007185
    PMA / PMN Number
    K213402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INARI DEVICES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. THE DEVICE IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION. 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. THE CASE WAS REVIEWED BY INARI'S CHIEF MEDICAL OFFICER, WHO CONCLUDED THAT THE PATIENT'S DEATH WAS POSSIBLY THE RESULT OF AN INADVERTENT CATHETER PERFORATION. HEMOPTYSIS, HYPOXEMIA, HYPOTENSION, VESSEL DISSECTION/PERFORATION, CARDIOGENIC SHOCK, CLINICAL DETERIORATION, AND DEATH ARE LISTED IN THE DEVICE LABELING AS POTENTIAL COMPLICATIONS / ADVERSE EVENTS.

    Description of Event or Problem · 0

    A 72-YEAR-OLD MALE WITH INTERMEDIATE HIGH-RISK PULMONARY EMBOLISM (PE) UNDERWENT A THROMBECTOMY WITH THE INARI FLOWTRIEVER SYSTEM. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SYMPTOMS OF DYSPNEA. THE PATIENT WAS TREATED WITH ANTICOAGULATION FOR A DAY PRIOR TO THE PROCEDURE. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED WHICH REVEALED LARGE THROMBUS FORMATIONS IN THE LEFT AND RIGHT PULMONARY ARTERIES. THE PATIENT ALSO HAD ELEVATED TROPONIN LEVELS WITH AN ENLARGED RIGHT ATRIUM (RA) AND RIGHT VENTRICLE (RV). ADDITIONALLY, THE PATIENT'S RIGHT VENTRICLE/LEFT VENTRICLE RATIO WAS LARGER THAN 1.4. THE PROCEDURE BEGAN WITH ACCESS GAINED FROM THE RIGHT COMMON FEMORAL VEIN. OBTAINING WIRE POSITIONING WAS DIFFICULT DUE TO THE PATIENT'S ENLARGED RV AND RA, BUT EVENTUALLY AN AMPLATZ SUPER STIFF GUIDEWIRE WAS PLACED IN A DEEP POSITION. THERE WAS NO SLACK IN THE RV, SO A TRIEVER16 (T16) WAS USED TO STABILIZE A TRIEVER24 (T24) AND ADVANCE IT TO THE RV. AN INITIAL ASPIRATION WAS PERFORMED WITH THE T16 WHICH REMOVED SOME UNORGANIZED CLOT. THE T16 WAS REMOVED, AND A TRIEVER20 CURVE (T20C) WAS USED TO ASPIRATE MORE THROMBUS IN THE RIGHT INTERLOBAR ARTERY. THIS RESULTED IN THE PATIENT EXPERIENCING AN INCREASE IN SPO2 AND DECREASE IN HEART RATE. THE T24 WAS ADVANCED BEHIND THE PULMONARY VALVE AND THE LEFT PULMONARY ARTERY WAS WIRED WITH A JR4 CATHETER AND J WIRE IN A BUDDY WIRE TECHNIQUE. THE AMPLATZ SUPER STIFF GUIDEWIRE WAS INSERTED VIA THE JR4 CATHETER. HOWEVER, DURING ADVANCEMENT OF THE T24 WITH T20C, THE PATIENT COMPLAINED OF CHEST PAIN AND FAINTED. THE PATIENT IMMEDIATELY DECOMPENSATED, AND A PERICARDIAL TAMPONADE WAS CONFIRMED BY ECHOCARDIOGRAPHY. THE PATIENT WAS INTUBATED AND PERICARDIOCENTESIS WAS PERFORMED. CARDIOPULMONARY RESUSCITATION WAS ALSO ADMINISTERED. A THORACIC SURGEON WAS CALLED, AND A STERNOTOMY WAS PERFORMED. THE SURGEON VISUALLY CONFIRMED THE TAMPONADE BUT WAS UNABLE TO STOP THE BLEEDING. THE PATIENT HAD A "DO NOT RESUSCITATE" ON FILE AND INTERVENTION WAS HALTED, UNFORTUNATELY THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458775 TRIEVER24 PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 22-101 24030058 00850291007185

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Life Threatening| R| D AMPLATZ SUPER STIFF GUIDEWIRE| J WIRE| JR4 CATHETER| TRIEVER16