BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIEVER24

    MDR report key: 19715427 · Received July 10, 2024

    Report

    Report Number
    3020347218-2024-00030
    Event Type
    Death
    Date Received
    July 10, 2024
    Date of Event
    June 11, 2024
    Report Date
    July 10, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007185
    PMA / PMN Number
    K213402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 DEATH WAS LIKELY THE RESULT OF DISTAL CLOT EMBOLISM. DISTAL EMBOLIZATION OF BLOOD CLOTS AND CARDIOVASCULAR COLLAPSE ARE IDENTIFIED IN THE DEVICE LABELING AS POSSIBLE ADVERSE EVENTS/COMPLICATIONS.

    Description of Event or Problem · 0

    A 64-YEAR-OLD MALE PRESENTED TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH AND AN EPISODE OF PRESYNCOPE. IMAGING WAS PERFORMED WHICH REVEALED A PULMONARY EMBOLISM, POSITIVE BIOMARKERS, AND EVIDENCE OF RIGHT HEART STRAIN. AFTER A CONSULTATION, IT WAS DETERMINED THAT THE PATIENT WOULD UNDERGO A THROMBECTOMY WITH THE INARI FLOWTRIEVER SYSTEM. THE PROCEDURE BEGAN WITHOUT ISSUE AND WIRE POSITIONING WAS OBTAINED. AN ACTIVATED CLOTTING TIME (ACT) TEST WAS PERFORMED WHICH RESULTED IN A VALUE OF 127. THIS LED TO AN ADJUSTMENT AND INCREASE IN ANTICOAGULATION TO REACH THE GOAL OF ACT 250-300. THE TRIEVER24 (T24) WAS ADVANCED INTO THE MID BASAL BRANCH AND AN ASPIRATION WAS PERFORMED. THIS RESULTED IN CAVITATION AND AN ADDITIONAL VACUUM WAS APPLIED. WHILE MAINTAINING WIRE POSITIONING, THE T24 WAS WALKED BACK AND SLOWLY FILLED. NO THROMBUS WAS SEEN. THE FLOWSAVER WAS USED, AND A SECOND ATTEMPT WAS MADE TO ASPIRATE. THIS ALSO RESULTED IN CAVITATION. CONTRAST WAS INJECTED TO VISUALIZE THE THROMBUS. A LARGE THROMBUS WAS OBSERVED ON THE TIP OF THE T24 OUTSIDE OF THE SHEATH. THE DECISION WAS MADE TO USE FLOWTRIEVER XL DISCS TO PREVENT RE-EMBOLISM BUT BEFORE THEY WOULD BE INSERTED, THE PHYSICIAN REMOVED THE T24 AND LOST THE THROMBUS. THE PATIENT BECAME RESTLESS AND TACHYCARDIC. MORE ASPIRATIONS WERE ATTEMPTED BUT THE RESULTS WERE THE SAME AS THE FIRST 2 ATTEMPTS. NO THROMBUS WAS REMOVED, AND THE PATIENT BECAME PROGRESSIVELY WORSE. THE RAPID RESPONSE TEAM WAS CALLED AND WORKED ON THE PATIENT FOR 15 MINUTES. EVENTUALLY, A FULL CODE WAS CALLED BUT DESPITE RESUSCITATION EFFORTS, THE PATIENT UNFORTUNATELY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364181 TRIEVER24 PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 22-101 00850291007185

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Life Threatening| D FLOWSAVER