BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIEVER24

    MDR report key: 22957420 · Received September 3, 2025

    Report

    Report Number
    3020347218-2025-00056
    Event Type
    Death
    Date Received
    September 3, 2025
    Date of Event
    August 4, 2025
    Report Date
    September 3, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007185
    PMA / PMN Number
    K213402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. 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 STRYKER MEDICAL AFFAIRS, WHO CONCLUDED THAT THE PATIENT'S INJURY WAS POSSIBLY THE RESULT OF INADVERTENT CATHETER PERFORATION DUE TO USER ERROR (ADVANCING WITHOUT A DILATOR). CARDIAC PERFORATION AND CARDIAC TAMPONADE ARE IDENTIFIED IN THE LABELING AS POSSIBLE ADVERSE EVENTS/COMPLICATIONS. THE DEVICE LABELING INCLUDES THE FOLLOWING WARNING: "DO NOT ADVANCE THE TRIEVER CATHETER WITHOUT FIRST REINSERTING THE DILATOR. FAILURE TO DO SO MAY RESULT IN VESSEL DAMAGE OR PERFORATION." MANUFACTURER REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    A 61-YEAR-OLD FEMALE PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH. IMAGING WAS PERFORMED AND THE PATIENT WAS DIAGNOSED WITH BILATERAL PULMONARY EMBOLISM (PE) WITH HEAVY CLOT BURDEN ON BOTH SIDES. CLOT WAS ALSO OBSERVED IN THE ILIAC AND INFERIOR VENA CAVA. ACCESS AND WIRE POSITIONING WAS ACHIEVED WITHOUT ISSUE. THE ACCESS SHEATH WAS SWAPPED OUT FOR THE INTRI24 SHEATH. AFTER REMOVING THE DILATOR, THE TRIEVER24 (T24) WAS ADVANCED INTO PLACE. ASPIRATIONS WERE PERFORMED BUT YIELDED LITTLE TO NO CLOT. CAVITATION ALSO OCCURRED SO THE PHYSICIAN PULLED BACK THE T24 UNTIL IT FILLED. THIS OCCURRED WHEN THE TIP OF THE T24 WAS IN THE MAIN PULMONARY ARTERY. WHEN THIS OCCURRED, THE PATIENT BEGAN TO COUGH AND EXPERIENCED A SMALL AMOUNT OF HEMOPTYSIS. THE PHYSICIAN ADVANCED THE T24 FORWARD WITHOUT A DILATOR TO TAKE AN ANGIOGRAM. NO SIGNS OF PERFORATION WERE SEEN SO THE PROCEDURE CONTINUED. ASPIRATIONS WERE PERFORMED BUT CAVITATION OCCURRED AGAIN. WHEN PULLING THE T24 BACK, THE SYRINGE WAS FILLED WITH A "JELLO-LIKE" CLOT. AFTER ANOTHER ASPIRATION THE PATIENT BEGAN TO EXPERIENCE SEVERE HEMOPTYSIS. SIGNIFICANT CLOT BURDEN WAS OBSERVED IN THE SYRINGE. SUCTION WAS PERFORMED AND THE T24 WAS PULLED BACK WHICH RESULTED IN THE LOSS OF WIRE POSITIONING. FORTUNATELY, THE PATIENT'S COUGHING AND HEMOPTYSIS RESOLVED ITSELF IN AROUND 10 MINUTES. THE PATIENT BEGAN TO RAPIDLY DETERIORATE AFTER BEING LAID DOWN. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED UNTIL A PULSE WAS REGAINED. EPINEPHRINE WAS ADMINISTERED AND ALL DEVICES WERE REMOVED FROM THE PATIENT. THE PATIENT WAS INTUBATED WHICH HELPED WITH STABILIZATION, BUT THE PATIENT CODED AGAIN. CPR WAS PERFORMED WITH OTHER RESUSCITATION EFFORTS UNTIL A PULSE WAS REGAINED. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT WHERE SHE PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734189 TRIEVER24 PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 22-101 00850291007185

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Death| L