BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIEVER24

    MDR report key: 14570532 · Received June 1, 2022

    Report

    Report Number
    3011525976-2022-00007
    Event Type
    Death
    Date Received
    June 1, 2022
    Date of Event
    April 1, 2022
    Report Date
    June 1, 2022
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007185
    PMA / PMN Number
    K213402
    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; HOWEVER, THE COMPANY RECORDED ALL LOTS SHIPPED TO THE FACILITY AND EACH OF THE POSSIBLE LOT HISTORY RECORDS 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 STROKE WAS THE RESULT OF DISTAL EMBOLIZATION, POTENTIALLY EXACERBATED BY A SUSPECTED PATENT FORAMEN OVALE AND THAT USE OF THE INARI DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S STROKE. HYPOXEMIA, DISTAL EMBOLISM, STROKE, CLINICAL DETERIORATION, AND DEATH ARE LISTED IN THE DEVICE LABELING AS POTENTIAL COMPLICATIONS / ADVERSE EVENTS. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    A FEMALE PATIENT IN HER EARLY 70S PRESENTED WITH DIFFICULTY BREATHING AND THE COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM REVEALED BILATERAL PULMONARY EMBOLISM (PE) AND DEEP VEIN THROMBOSIS (DVT) IN THE LEFT LEG. ON (B)(6) 2022, THE INARI TRIEVER24 (T24) WAS USED TO ATTEMPT TO REMOVE THE PE. THE PATIENT WAS GIVEN LOCAL ANESTHESIA WITH SEDATION AND SYSTEMIC HEPARIN. SEVEN (7) PASSES WERE MADE WITH THE T24, YIELDING APPROXIMATELY 70% OF THE CLOT BURDEN; HOWEVER, CATHETER CAVITATION WITH THE T24 OCCURRED TWICE DURING ASPIRATION ATTEMPTS. DURING THE PROCEDURE THE PATIENT EXPERIENCED A PARADOXICAL STROKE IN THE MAIN CORONARY ARTERY; A PATENT FORAMEN OVALE (PFO) WAS SUSPECTED. THE PATIENT WAS GIVEN COMFORT CARE AND DIED AROUND 3:00 AM ON (B)(6) 2022. ADDITIONAL INFORMATION WAS REQUESTED FROM THE INITIAL REPORTER ON SEVERAL OCCASIONS, BUT NO RESPONSE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631413 TRIEVER24 THROMBECTOMY SYSTEM QEW INARI MEDICAL, INC. 22-101 00850291007185

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Life Threatening| D| H AMPLATZ GUIDEWIRE| FLOWSAVER| GORE DRYSEAL SHEATH 26 FR| SWAN CATHETER