BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIEVER24

    MDR report key: 9814083 · Received March 10, 2020

    Report

    Report Number
    3011525976-2020-00003
    Event Type
    Death
    Date Received
    March 10, 2020
    Date of Event
    February 9, 2020
    Report Date
    March 10, 2020
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007185
    PMA / PMN Number
    K191710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. DISTAL EMBOLIZATION IS LISTED IN THE DEVICE LABELING AS A POTENTIAL COMPLICATION / ADVERSE EVENT. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    A (B)(6)-YEAR-OLD MALE PATIENT WAS ADMITTED THROUGH THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH AND STERNAL CHEST PAIN; THE PATIENT HAD BEEN SYMPTOMATIC FOR 2+ WEEKS, WITH SYMPTOMS WORSENING ON THE DAY OF ADMISSION. DIAGNOSTIC CT ANGIOGRAPHY REVEALED SADDLE PULMONARY EMBOLISM WITH LARGE BILATERAL CLOT BURDEN, DILATED PULMONARY ARTERIES, AND A RV/LV RATIO OF APPROXIMATELY 2.2. THE PATIENT'S VITAL SIGNS WERE: HEART RATE 101 BPM, BLOOD PRESSURE 102/72 MMHG, PULMONARY ARTERY PRESSURE 60/16/31 (SYSTOLIC/DIASTOLIC/MEAN), AND BLOOD OXYGENATION SATURATION 93% ON 15 L/MIN OXYGEN. ON (B)(6) 2020, THE INARI TRIEVER24 WAS USED TO THE TREAT THE PATIENT'S PULMONARY EMBOLISM. ACCESS THROUGH THE RIGHT HEART WAS DIFFICULT, AND A GUIDEWIRE HAD TO BE PLACED WITHOUT A CATHETER TO ACCESS THE PULMONARY ARTERY (PA). A 10 X 40 MM BALLOON WAS ADVANCED, INFLATED, AND WITHDRAWN WITHOUT RESISTANCE, CONFIRMING THE GUIDEWIRE WAS NOT UNDERNEATH A CHORDAE TENDINEAE. THE ANATOMY WAS CHALLENGING WITH A LONG PULMONARY TRUNK AND AN ACUTE TURN INTO THE RIGHT PA, WHICH MADE ACCESS INTO THE RIGHT PA DIFFICULT AS THE GUIDEWIRE/CATHETER WOULD RETURN TO ITS PREVIOUS POSITION IN THE LEFT PA. RIGHT PA ACCESS WAS EVENTUALLY OBTAINED AND AN AMPLATZ SUPER STIFF GUIDEWIRE (1 CM) WAS PLACED INTO THE RIGHT BASAL TRUNK. COUGHING WAS NOTED DURING GUIDEWIRE PLACEMENT, BUT THE WIRE WAS NOT POSITIONED TOO FAR DISTALLY; THE COUGHING WAS NOT SEVERE AND THERE WAS NO HEMOPTYSIS. THE TRIEVER24 WAS ADVANCED SUCCESSFULLY OVER THE GUIDEWIRE INTO THE RIGHT PA, BUT MARKED DIFFICULTY WAS NOTED WHEN ATTEMPTING TO ADVANCE FROM THE MAIN PA INTO THE RIGHT PA. SEVERAL ASPIRATIONS WERE MADE IN THE INTERLOBAR ARTERY WITH VERY ORGANIZED CLOT REMOVED ON ALL BUT ONE ASPIRATION. IT WAS THEN DECIDED TO USE THE INARI FLOWTRIEVER CATHETER TO HELP DISLODGE THE REMAINING CLOT. AS THE TRIEVER24 WAS REPOSITIONED PROXIMALLY, IT RETURNED TO ITS PREVIOUS POSITION IN THE LEFT PA. THE DILATOR WAS REINSERTED AND ACCESS TO THE RIGHT WAS ATTEMPTED AGAIN, BUT THE TRIEVER24 WOULD NOT MAKE THE TRANSITION FROM THE VERY PROXIMAL RIGHT PA TO A MORE DISTAL POSITION IN THE RIGHT PA. THE DILATOR TIP WAS RETRACTED SLIGHTLY, SO THAT IT WAS FLUSH WITH THE DISTAL EDGE OF THE TRIEVER24 AND SLIGHT RESISTANCE WAS NOTED AGAIN. AS THE TRIEVER24 WAS BEING ADVANCED, TENSION IN THE SYSTEM "RELEASED" AND THE TRIEVER24 SUDDENLY ADVANCED FORWARD FROM THE VERY PROXIMAL RIGHT PA TO THE INTERLOBAR/BASAL TRUNK JUNCTION. AS THE TRIEVER24 MOVED FORWARD, THE WIRE RETRACTED BACK INTO THE TRIEVER24 AND THE PHYSICIAN RETRACTED THE TRIEVER24 INTO A MORE PROXIMAL POSITION. APPROXIMATELY 30 SECONDS LATER, THE PATIENT BECAME EXTREMELY UNCOMFORTABLE AND ATTEMPTED TO SIT UP STATING THAT HE COULD NOT BREATHE. A CODE WAS INITIATED AND THE RAPID RESPONSE TEAM ARRIVED WITHIN ONE MINUTE. THE PATIENT BECAME UNSTABLE WITH HEART RATE ELEVATION >150 BPM AND DECREASING SAO2. THE PATIENT WAS INTUBATED, AND HR DECREASED TO <30 BPM, THEN ARRESTING AND CHEST COMPRESSIONS WERE INITIATED. FULL RESUSCITATION EFFORTS COMMENCED FOR ROUGHLY 30 MINUTES BEFORE THE PATIENT WAS TRANSFERRED TO THE CARDIAC INTENSIVE CARE UNIT FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). IN LATER DISCUSSION WITH THE TREATING PHYSICIAN AND THE FELLOW ON THE EVENTS AND REVIEW OF THE PA ARTERIOGRAM, A VESSEL PERFORATION WAS RULED OUT. THE CAUSE OF THE DECOMPENSATION/CARDIAC ARREST EVENT WAS ATTRIBUTED TO A COMBINATION OF THE PATIENT'S PREEXISTING TENUOUS CONDITION WITH SIGNIFICANT CLOT BURDEN AND ABNORMAL ANATOMY WHICH LED TO THE CLOT DISLODGING DISTALLY INTO THE RIGHT PA. WITH SYMPTOMS PERSISTING FOR 2+ WEEKS BEFORE SEEKING TREATMENT, THE PATIENT DID NOT HAVE ANY CARDIOPULMONARY RESERVE, WHICH CAUSED THE ACUTE AND SUDDEN DECOMPENSATION. THE INARI DEVICE WAS NOT SUSPECTED AS CAUSING THE EVENT. THE CASE WAS REVIEWED WITH THE INARI CHIEF MEDICAL OFFICER, WHO LEARNED THAT THE PATIENT LATER EXPIRED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275593 TRIEVER24 EMBOLECTOMY CATHETER QEW INARI MEDICAL, INC. 22-101 19120017 00850291007185

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| H| L