BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLOWTRIEVER RETRIEVAL ASPIRATION SYSTEM

    MDR report key: 8197150 · Received December 26, 2018

    Report

    Report Number
    3011525976-2018-00003
    Event Type
    Death
    Date Received
    December 26, 2018
    Date of Event
    December 6, 2018
    Report Date
    December 26, 2018
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    DXE
    UDI-DI
    00850291007079
    PMA / PMN Number
    K182233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE USER FACILITY AND IS THEREFORE NOT AVAILABLE FOR ANALYSIS. THE DEVICE HISTORY RECORDS FOR THIS MANUFACTURING LOT WERE REVIEWED AND THERE WERE NO ANOMALIES, DISCREPANCIES, OR NON-CONFORMANCES. DAMAGE TO THE HEMOSTASIS VALVE (HISSING SOUND) WAS NOT BELIEVED TO BE RESPONSIBLE FOR THE HEMOPTYSIS. ACCORDING TO THE INARI MEDICAL CONSULTANT'S EXPERT OPINION, THE PATIENT BLED TO DEATH DUE TO HEMOPTYSIS CAUSED BY PERFORATION; THE LIKELY SOURCE WAS EITHER GUIDEWIRE PERFORATION OR VACUUM ASPIRATION DAMAGING THE VESSEL WALL. HEMOPTYSIS AND DEATH ARE LISTED IN THE DEVICE LABELING AS POTENTIAL COMPLICATIONS ASSOCIATED WITH THROMBECTOMY PROCEDURES. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018, A LATE-STAGE MULTIPLE MYELOMA PATIENT WITH METASTATIC CANCER PRESENTED IN THE EMERGENCY DEPARTMENT WITH DYSPNEA AND DIZZINESS. CT ANGIOGRAPHY CONFIRMED A SADDLE, BILATERAL PULMONARY EMBOLUS. HIS RIGHT VENTRICLE/LEFT VENTRICLE (RV/LV) RATIO WAS ELEVATED AT 1.5, 2L OF OXYGEN, HR: 92, BP: 112/77, AND PULMONARY ARTERY PRESSURE WAS ELEVATED AT 50/26/36 (SYSTOLIC/DIASTOLIC/MEAN MMHG). THE HISTORY OF PRIOR CHEST RADIATION WAS UNKNOWN. THE PATIENT WAS TRANSFERRED TO THE "CATHERIZATION" LABORATORY WHERE THE INTERVENTIONAL CARDIOLOGIST GAINED ACCESS THROUGH THE GROIN USING THE ASPIRATION GUIDE CATHETER (AGC) VIA ULTRASOUND AND CROSSED THE HEART WITH A PIGTAIL CATHETER. HEMODYNAMIC MEASUREMENTS AND PULMONARY ANGIOGRAPHY REVEALED A PROXIMAL THROMBUS IN THE TRUNCUS ANTERIOR AND MIDDLE LOBAR SEGMENTS. BLOOD PRESSURE BECAME UNSTABLE. THE PIGTAIL CATHETER WAS REPLACED WITH THE AMPLATZ SUPERSTIFF GUIDEWIRE. STARTING IN THE RIGHT PULMONARY ARTERY (PA), AN ACUTE/CHRONIC CLOT WAS EXTRACTED VIA ASPIRATION WITH THE 60 CC SYRINGE (SUPPLIED AS PART OF THE AGC SYSTEM). THE TRUNCUS ANTERIOR WAS OBSTRUCTED, PREVENTING GUIDEWIRE ACCESS. THE AGC WAS REINSERTED AND PLACED INTO THE LEFT PA, BUT NO CLOT WAS EXTRACTED. THE AGC WAS REINSERTED INTO THE RIGHT PA AND THE SADDLE CLOT WAS ASPIRATED WITH THE 60 CC SYRINGE. THE AGC WAS POSITIONED TO THE LEFT PA; THE GUIDEWIRE WAS RETRACTED INTO AGC AND VACUUM WAS PULLED WITH THE 60 CC SYRINGE; AT THIS TIME A HISSING SOUND WAS HEARD WITH CAVITATION NOTED IN THE SYRINGE. THE PATIENT COUGHED THEN STARTED COUGHING UP A LARGE VOLUME OF BLOOD, ESTIMATED AT 300-500 CC; HEPARIN WAS DISCONTINUED AND PROTAMINE ADMINISTERED. THE PATIENT DETERIORATED FURTHER, ARRESTED, AND A CODE WAS CALLED. DURING RESUSCITATION, A PULSE WAS REGAINED. BRONCHOSCOPY AND PULMONARY ANGIOGRAPHY ON RIGHT SIDE DID NOT REVEAL THE SOURCE OF BLEEDING. THE PATIENT ARRESTED AGAIN AND CPR WAS ADMINISTERED AND A PULSE WAS REGAINED TEMPORARILY; HOWEVER, THE PATIENT ARRESTED A THIRD TIME. CPR CONTINUED FOR APPROXIMATELY ONE HOUR, BUT THE TEAM WAS UNABLE TO REGAIN A PULSE AND THE PATIENT EXPIRED. FINAL PULMONARY ANGIOGRAM DID NOT REVEAL EXTRAVASATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034938 FLOWTRIEVER RETRIEVAL ASPIRATION SYSTEM EMBOLECTOMY CATHETER DXE INARI MEDICAL, INC. 21-101 18100001 00850291007079

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death PIGTAIL CATHETER, AMPLATZ SUPERSTIFF GUIDEWIRE