BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIEVER24

    MDR report key: 10498017 · Received September 5, 2020

    Report

    Report Number
    3011525976-2020-00018
    Event Type
    Death
    Date Received
    September 5, 2020
    Date of Event
    August 7, 2020
    Report Date
    September 5, 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 THE MANUFACTURING LOTS AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. THE CASE WAS REVIEWED BY INARI'S CHIEF MEDICAL OFFICER, WHO CONCLUDED THAT USE ERROR WITH THE INARI DEVICE(S) LIKELY CAUSED THE VESSEL PERFORATION. FACTORS THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S DETERIORATION AND SUBSEQUENT DEATH INCLUDE PROCEDURAL INTUBATION/GENERAL ANESTHESIA AND CO-MANAGEMENT WITH THROMBOLYTIC MEDICATION. 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. VESSEL PERFORATION, HEMOPTYSIS, CARDIOGENIC SHOCK, AND DEATH ARE LISTED IN THE DEVICE LABELING AS POTENTIAL COMPLICATIONS / ADVERSE EVENTS. (B)(4).

    Description of Event or Problem · 1

    A (B)(6)-YEAR-OLD FEMALE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH ON (B)(6) 2020. SHE WAS TRANSFERRED TO ANOTHER HOSPITAL, WHERE A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED A PULMONARY EMBOLISM (PE). THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT, WHERE SHE WAS PLACED ON SYSTEMIC HEPARIN. THE PATIENT DID NOT IMPROVE BY THE EARLY EVENING OF (B)(6) 2020; THEREFORE THE INTERVENTIONAL RADIOLOGIST SCHEDULED A THROMBECTOMY USING THE INARI MEDICAL TRIEVER24 (T24) TO ADDRESS THE PE. PRIOR TO THE CASE, THE PATIENT'S VITAL SIGNS WERE: RV/LV RATIO 2.14, HEART RATE 102 BPM, BLOOD PRESSURE 140/93, OXYGEN SATURATION 95% ON 50 L/MIN, AND 13.6 G/DL HEMOGLOBIN. THE PATIENT HAD EATEN EARLIER IN THE DAY SO THE ANESTHESIOLOGIST INTUBATED THE PATIENT AND ADMINISTERED GENERAL ANESTHESIA. USING ULTRASOUND AND A MICROPUNCTURE KIT, THE PHYSICIAN GAINED ACCESS VIA THE RIGHT FEMORAL VEIN. AN EXCHANGE CATHETER WAS PLACED OVER THE WIRE, THEN A BOSTON SCIENTIFIC AMPLATZ SUPER STIFF GUIDEWIRE WAS INSERTED THROUGH THE EXCHANGE CATHETER AND INTO THE INFERIOR VENA CAVA. THE MICROPUNCTURE SHEATH WAS THEN EXCHANGED FOR A 24F GORE DRYSEAL SHEATH AND 7000 UNITS OF HEPARIN WERE ADMINISTERED. THE AMPLATZ GUIDEWIRE WAS REMOVED AND AN ANGLED PIGTAIL CATHETER CONTAINING A COOK MEDICAL BENTSON WIRE GUIDE WAS USED TO CROSS THE RIGHT HEART TO THE MAIN PULMONARY ARTERY (PA) WHICH HAD A MEAN PULMONARY ARTERIAL PRESSURE OF 47 MMHG. TWO HAND INJECTIONS WERE PERFORMED TO CAPTURE IMAGES OF THE MAIN PA AND THE RIGHT AND LEFT PAS, RESPECTIVELY. THE PIGTAIL CATHETER WAS EXCHANGED FOR A GLIDEWIRE AND A 5 FR VERTEBRAL CATHETER WHICH WERE USED TO ACCESS THE LATERAL BASAL SEGMENTAL BRANCH OF THE RIGHT LUNG LOWER LOBE. THE GLIDEWIRE WAS REMOVED, AND THE AMPLATZ GUIDEWIRE WAS REINTRODUCED AFTER IMAGING WAS PERFORMED TO CONFIRM THE POSITION OF THE VERTEBRAL CATHETER. THE VERTEBRAL CATHETER WAS REMOVED, AND THE T24 WAS INSERTED AND ADVANCED THROUGH THE RIGHT HEART AND INTO THE RIGHT PA AT THE PROXIMAL EDGE OF THE CLOT IN THE RIGHT INTERLOBAR PA. AFTER THE DILATOR WAS REMOVED FROM THE T24, TWO ASPIRATIONS WERE PERFORMED, BOTH OF WHICH YIELDED A SIGNIFICANT AMOUNT OF CLOT. AT THIS POINT, THE PATIENT BEGAN TO DECOMPENSATE SLIGHTLY. THE DECISION WAS MADE TO GENTLY PULL THE T24 BACK AND ATTEMPT TO ACCESS THE TRUNCUS ANTERIOR (TA). HOWEVER, THE WIRE POSITION BECAME LOST WHEN THE T24 WAS WITHDRAWN INTO THE MAIN PA. IN ORDER TO REGAIN THE CORRECT POSITION, THE VERTEBRAL CATHETER WAS PLACED THROUGH THE T24 TO OBTAIN IMAGES OF THE TA AND RIGHT PA. THE GLIDEWIRE WAS THEN INSERTED AND ADVANCED TO THE RIGHT UPPER LOBE APICAL SEGMENTAL BRANCH OF THE TA. THE VERTEBRAL CATHETER WAS ADVANCED TO THE GLIDEWIRE'S POSITION, AND THE GLIDEWIRE WAS AGAIN EXCHANGED FOR THE AMPLATZ GUIDEWIRE. THE DILATOR WAS REINSERTED INTO THE T24 BEFORE THE DEVICE WAS ADVANCED FROM THE MAIN PA TOWARD THE TA. HOWEVER, THE GUIDEWIRE POSITION WAS LOST AGAIN, DESPITE MULTIPLE ATTEMPTS TO ACCESS THE TA. AS THE PATIENT CONTINUED TO DECOMPENSATE, THE PHYSICIAN WAS ABLE TO POSITION THE T24 AT THE BIFURCATION OF THE TA AND RIGHT INTERLOBAR PA. TWO ASPIRATIONS WERE PERFORMED, BUT NO CLOT WAS RETRIEVED. DUE TO THE PATIENT'S DETERIORATING CONDITION, THE PHYSICIAN ELECTED TO PULL THE T24 BACK INTO THE MAIN PA TO ATTEMPT TO ASPIRATE THE LEFT SIDE. ADDITIONALLY, 10 MG OF TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED AT THIS TIME. AS THE T24 WAS WITHDRAWN BACK INTO THE MAIN PA, THE PATIENT ARRESTED. CHEST COMPRESSIONS WERE INITIATED AND THE PATIENT WAS RESUSCITATED AND STABILIZED. HOWEVER, AS ANOTHER IMAGE OF THE MAIN PA WAS BEING TAKEN, THE ANESTHESIOLOGIST OBSERVED HEMOPTYSIS AND INITIATED SUCTIONING. THE PERFORMING PHYSICIAN PROCEEDED WITH AN ATTEMPT TO ACCESS THE LEFT LOWER LOBE LATERAL SEGMENTAL BRANCH USING THE GLIDEWIRE AND VERTEBRAL CATHETER, BUT COULD NOT GAIN PURCHASE. NO PERFORATION WAS SEEN DURING THIS TIME, BUT THE PATIENT BEGAN DECOMPENSATING AGAIN. THE AMPLATZ GUIDEWIRE WAS INSERTED AND PLACED AS FAR DISTALLY AS POSSIBLE IN THE LEFT INTERLOBAR ARTERY. WITH THE DILATOR IN PLACE, THE T24 WAS ADVANCED SLIGHTLY INTO THE LEFT PA. THE PATIENT CONTINUED TO DECOMPENSATE, AND THE DECISION TO USE THE INARI TRIEVER16 (T16) AS A "RAIL" FOR THE T24 WAS MADE. AS THE T16 WAS BEING PREPARED, THE PHYSICIAN ATTEMPTED TWO ASPIRATIONS WITH THE T24 AND WAS ABLE TO REMOVE A SMALL AMOUNT OF CLOT. A PIGTAIL CATHETER WAS THEN INSERTED TO TAKE IMAGES ON THE LEFT SIDE, WHICH REVEALED A PSEUDOANEURYSM IN THE LEFT UPPER LOBE/LINGULAR AREA. AFTER THE GUIDEWIRE WAS REPLACED IN THE LEFT INTERLOBAR ARTERY, THE T16 WAS INSERTED AND ADVANCED THROUGH THE T24 TO THAT LOCATION. AN ASPIRATION WAS ATTEMPTED, BUT THE PATIENT ARRESTED AGAIN WITH ESCALATING HEMOPTYSIS. CHEST COMPRESSIONS WERE INITIATED AND EMERGENCY BLOOD AND PROTAMINE WERE ADMINISTERED; THE PATIENT WAS ABLE TO BE RESUSCITATED AND STABILIZED. THE T24 AND T16 WERE REMOVED FROM THE PATIENT AND AN ENDOTRACHEAL TUBE WAS PLACED IN THE RIGHT MAIN PA. PICTURES TAKEN WERE TAKEN THROUGH THE PIGTAIL ON THE RIGHT AND LEFT SIDES, THE LATTER OF WHICH REVEALED A PERFORATION. CARDIOTHORACIC SURGERY WAS CONSULTED, AND THE DECISION WAS MADE TO HAVE THE INTERVENTIONAL RADIOLOGIST COIL THE PERFORATION. HOWEVER, THE PATIENT CODED FOR A THIRD TIME, RESUSCITATION EFFORTS WERE ULTIMATELY UNSUCCESSFUL, AND THE PATIENT EXPIRED. THIS REPORT RELATES TO THE INARI TRIEVER24 DEVICE. REFER TO MDR #3011525976-2020-00019 FOR THE INARI TRIEVER16 DEVICE INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962449 TRIEVER24 EMBOLECTOMY CATHETER QEW INARI MEDICAL, INC. 22-101 20030005 00850291007185

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| L