BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INARI TRIEVER24

    MDR report key: 11996138 · Received June 14, 2021

    Report

    Report Number
    3011525976-2021-00014
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    May 15, 2021
    Report Date
    June 14, 2021
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007185
    PMA / PMN Number
    K211013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE T24 DEVICE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE IDENTIFIERS WERE PROVIDED AND THE 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 EVENT DETAILS WERE REVIEWED BY INARI'S CHIEF MEDICAL OFFICER, WHO CONCLUDED THAT THE PATIENT'S SEVERE DISEASE STATE PRECLUDED HIS HEART FROM TOLERATING THE LARGE-BORE CATHETER, AND THAT USE OF THE T24 MAY HAVE CONTRIBUTED TO THE PATIENT'S DETERIORATION. GENERAL DISCOMFORT, TENDERNESS OR PAIN, BRADYCARDIA, HYPOTENSION, CLINICAL DETERIORATION, AND CARDIOGENIC SHOCK ARE LISTED IN THE DEVICE LABELING AS POTENTIAL COMPLICATIONS/ADVERSE EVENTS. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    A (B)(6)-YEAR-OLD MALE PATIENT WITH PROSTATE CANCER AND DIABETES PRESENTED TO THE HOSPITAL WITH LOWER EXTREMITY SWELLING AND SHORTNESS OF BREATH. A CT ANGIOGRAM REVEALED CLOT-IN-TRANSIT (CIT) AND SIGNIFICANT BILATERAL CLOT BURDEN. ON (B)(6) 2021, THE INARI MEDICAL TRIEVER24 (T24) WAS USED TO ATTEMPT TO TREAT THE PATIENT'S SUBMASSIVE PULMONARY EMBOLISM. PRIOR TO SURGICAL TREATMENT, THE PATIENT WAS GIVEN HEPARIN INTRAVENOUSLY. A BOSTON SCIENTIFIC AMPLATZ SUPER STIFF GUIDEWIRE WAS ADVANCED TO THE LEFT PULMONARY ARTERY (PA). THE T24 WAS THEN POSITIONED IN THE RIGHT ATRIUM AND TWO CLOT ASPIRATIONS WERE PERFORMED SUCCESSFULLY. AS THE T24 WAS ADVANCED TO THE LEFT PA, THE PATIENT REPORTED GROIN PAIN. THE PATIENT'S PA PRESSURE WAS 60/40 MMHG AND 2 ADDITIONAL ASPIRATIONS YIELDED MODERATE CLOT. THE T24 WAS RETRACTED BACK TO THE LEFT MAIN PA WHEN THE PATIENT BECAME EXTREMELY AGITATED, REACHING FOR HIS GROIN AND DISPLACING THE ARTERIAL LINE. THE PHYSICIAN INJECTED LIDOCAINE AROUND THE GROIN TO ADDRESS THE PAIN. THE COMPANY REPRESENTATIVE PRESENT DURING THE CASE RECOMMENDED REMOVING THE T24 FROM THE HEART, BUT THE PHYSICIAN PROCEEDED TO STOP LIDOCAINE INJECTIONS AND ATTEMPTED TO WIRE INTO THE RIGHT PA. THE PATIENT DETERIORATED AND A CODE WAS INITIATED. THE PATIENT STABILIZED AFTER VASOPRESSORS WERE ADMINISTERED AND CHEST COMPRESSIONS WERE CONDUCTED; 50 MG OF TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS GIVEN. THE PHYSICIAN ELECTED TO CONTINUE TO TREAT THE CLOT REMAINING IN THE RIGHT PA. THE COMPANY REPRESENTATIVE RECOMMENDED DISCONTINUING USE OF THE T24 TO MINIMIZE STRESS ON THE HEART. A RIGHT PA PRESSURE MEASUREMENT OF 70/24 MMHG WAS OBTAINED BEFORE THE PHYSICIAN DELIVERED THE PENUMBRA LIGHTNING 12 CATHETER INTO THE RIGHT PA. THE PENUMBRA DEVICE WAS POWERED ON, BUT NO CLOT WAS ASPIRATED. THE PATIENT ARRESTED A SECOND TIME AND CPR WAS ADMINISTERED UNTIL THE PATIENT STABILIZED. AT THE LAST UPDATE RECEIVED ON MAY 17, 2021, THE PATIENT HAD BEEN TRANSFERRED TO THE ICU AND WAS ON VASOPRESSOR MEDICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886173 INARI TRIEVER24 EMBOLECTOMY CATHETER QEW INARI MEDICAL, INC. 22-101 20060007 00850291007185

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R