BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLOTTRIEVER BOLD CATHETER

    MDR report key: 17269174 · Received July 6, 2023

    Report

    Report Number
    3020347218-2023-00012
    Event Type
    Death
    Date Received
    July 6, 2023
    Date of Event
    June 7, 2023
    Report Date
    July 6, 2023
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007314
    PMA / PMN Number
    K230494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 NOT PROVIDED, THE LOT HISTORY RECORDS OF ALL POTENTIAL LOTS SHIPPED TO THE FACILITY 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 DETERIORATION WAS THE RESULT OF CLOT EMBOLISM. DISTAL EMBOLIZATION OF BLOOD CLOTS AND CARDIOVASCULAR COLLAPSE ARE LISTED IN THE DEVICE LABELING AS POTENTIAL COMPLICATIONS / ADVERSE EVENTS. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    A 66-YEAR-OLD MALE PATIENT WAS DIAGNOSED WITH LEFT LOWER EXTREMITY ILIO-FEMORAL DEEP VEIN THROMBOSIS (DVT). THE CLOT AGE WAS ESTIMATED AT 3 DAYS. ON (B)(6) 2023, A THROMBECTOMY WAS PLANNED WITH THE INARI CLOTTRIEVER (CT) BOLD CATHETER WITH LEFT POPLITEAL ACCESS. A VENOGRAM WAS PERFORMED WHICH REVEALED EXTENSIVE CLOT BURDEN FROM THE POPLITEAL VEIN TO THE ILIAC VEIN. NO CLOT WAS IDENTIFIED IN THE INFERIOR VENA CAVA (IVC). THE SURGICAL PLAN WAS TO PERFORM THE THROMBECTOMY WITHOUT DISTAL PROTECTION DUE TO THE CLOT LOCATION. WIRE POSITIONING WAS OBTAINED WITH AN AMPLATZ GUIDEWIRE, AND THE CT BOLD CATHETER WAS ADVANCED. THREE PASSES WERE PERFORMED WHICH SUCCESSFULLY RETRIEVED A LARGE CLOT BURDEN. A VENOGRAM WAS TAKEN AFTER THE THIRD PASS WHICH REVEALED A LARGE THROMBUS IN THE ILIAC/IVC HAD FLOATED UP FROM WHAT WAS PRESUMED TO BE THE PROFUNDA ARTERY. THE PHYSICIAN REPOSITIONED TO ADDRESS THIS CLOT. A FOURTH PASS WAS MADE, BUT IT DID NOT COLLECT A SUFFICIENT AMOUNT OF CLOT. AT THIS POINT, THE PATIENT BECAME RESTLESS, TACHYCARDIC, AND HYPOXIC. A PULMONARY EMBOLISM (PE) WAS SUSPECTED AND THE PATIENT WAS REPOSITIONED FROM THE PRONE POSITION TO SUPINE IN ORDER TO ACCESS THE RIGHT COMMON FEMORAL VEIN. AN ECHOCARDIOGRAM REVEALED A DILATED RIGHT VENTRICLE WITH RIGHT VENTRICLE FAILURE AND CONFIRMED THE PRESENCE OF A PE. THE PATIENT CONTINUED TO RAPIDLY DECLINE AS THE FLOWTRIEVER CATHETER WAS BEING ADVANCED TO THE PULMONARY ARTERIES. THE PATIENT ARRESTED, A CODE WAS INITIATED, AND CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED. A SUCCESSFUL PE THROMBECTOMY WAS PERFORMED AND TPA WAS ADMINISTERED. CPR WAS PERFORMED FOR A TOTAL OF 36 MINUTES AND THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). AFTER THE PE THROMBECTOMY, AN ECHOCARDIOGRAM SHOWED A NORMAL RIGHT VENTRICLE. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT REMAINED IN THE ICU ON ECMO SUPPORT FOR 5 DAYS, BUT DID NOT RECOVER NEUROLOGICALLY. THE DECISION WAS EVENTUALLY MADE TO WITHDRAW LIFE SUPPORT AND THE PATIENT DIED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931821 CLOTTRIEVER BOLD CATHETER PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 42-102 00850291007314

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death| R| L| H AMPLATZ GUIDEWIRE| CLOTTRIEVER SHEATH, 13 FR