BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTRIEVE SHEATH

    MDR report key: 19878717 · Received July 31, 2024

    Report

    Report Number
    3020347218-2024-00035
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    July 2, 2024
    Report Date
    July 31, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    PMA / PMN Number
    K230331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 DISTAL CLOT EMBOLISM. MANUFACTURER REFERENCE #: (B)(4). DISTAL EMBOLIZATION OF BLOOD CLOTS IS IDENTIFIED IN THE DEVICE LABELING AS POSSIBLE ADVERSE EVENTS/COMPLICATIONS.

    Description of Event or Problem · 0

    A 42-YEAR-OLD OVERWEIGHT FEMALE ARRIVED AT THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF ABDOMINAL PAIN. WHILE THE PATIENT WAS HEMODYNAMICALLY STABLE, BILATERAL DEEP VEIN THROMBOSIS (DVT) AND A CLOTTED FILTER WAS DISCOVERED. ADDITIONALLY, THE PATIENT HAD A PULMONARY EMBOLISM (PE) SEVERAL MONTHS PRIOR IN WHICH SHE WAS SENT HOME ON ELIQUIS AFTER BEING TREATED WITH MECHANICAL THROMBECTOMY AND A FILTER WAS PLACED. DURING THE PATIENT'S STAY AT THE HOSPITAL, THE PATIENT UNDERWENT A PE AND DVT THROMBECTOMY ON 2 DIFFERENT DAYS. HOWEVER, THE PATIENT RE-CLOTTED AFTER THE DVT PROCEDURE SO ANOTHER THROMBECTOMY HAD TO BE PERFORMED. THE THIRD THROMBECTOMY BEGAN WITHOUT ISSUE AND THE PATIENT WAS HEMODYNAMICALLY STABLE AT THE START OF THE CASE. INTERNAL JUGULAR ACCESS WAS OBTAINED, AND A PROTRIEVE SHEATH (PT) WAS INSERTED. THE PT WAS SECURED WITH A SUTURE AND FLOWSTASIS. A VENOGRAM WAS PERFORMED WHICH REVEALED A CLOT IN THE INFERIOR VENA CAVA (IVC) FILTER DOWN TO THE FEMORAL VEIN ON THE LEFT. A TRIEVER20 (T20) CATHETER WAS USED TO ASPIRATE THE CLOT WITHIN THE IVC FILTER BEFORE REMOVING THE FILTER. A CLOTTRIEVER XL CATHETER (CTXL) WAS THEN USED TO PERFORM PASSES. HOWEVER, AFTER THE 4TH PASS, THE PATIENT EXPERIENCED A BLOOD PRESSURE DROP AND HEART RATE SPIKE. A CODE WAS CALLED. IT WAS ASSUMED THAT THE PATIENT HAD THROWN A PE AFTER IT WAS OBSERVED THAT THE PT SHEATH HAD SLIPPED BACK DURING THE PROCEDURE, SO THE PROCEDURE SWITCHED TO A PE THROMBECTOMY. THE T20 WAS USED TO ASPIRATE THE RIGHT AND LEFT LUNGS. AN ANGIOGRAM WAS PERFORMED WHICH REVEALED CLOT REMAINING IN THE LEFT SO MORE ASPIRATIONS WERE PERFORMED. ANGIOGRAMS THEN SHOWED PERFUSION IN THE LUNGS. DURING THIS TIME, THE PATIENT WAS RECEIVING CHEST COMPRESSIONS AND WAS HOOKED UP TO A VENTILATOR. THE PATIENT BECAME STABLE ENOUGH TO MOVE HER TO THE INTENSIVE CARE UNIT WHERE SHE REMAINED INTUBATED AND STILL ON PRESSORS. THE PATIENT WAS ALERT AND WAS ABLE TO FOLLOW COMMANDS WHEN THE SEDATION WORE OFF. A COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED ONLY SUB-SEGMENTAL CLOT IN THE LUNGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220858 PROTRIEVE SHEATH PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 60-101

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention| H| L CLOTTRIEVER XL CATHETER| TRIEVER20