BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLOTTRIEVER CATHETER

    MDR report key: 14115860 · Received April 14, 2022

    Report

    Report Number
    3011525976-2022-00006
    Event Type
    Death
    Date Received
    April 14, 2022
    Date of Event
    March 17, 2022
    Report Date
    April 14, 2022
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007093
    PMA / PMN Number
    K212632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. 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 DEATH WAS THE RESULT OF RIGHT HEART FAILURE. THE RELATIONSHIP BETWEEN THE EVENT AND THE INARI DEVICES IS NOT KNOWN, BUT THERE IS NO EVIDENCE OF USE ERROR OR DEVICE MALFUNCTION. CARDIOVASCULAR COLLAPSE AND PATIENT DETERIORATION ARE IDENTIFIED IN THE DEVICE LABELING AS POTENTIAL COMPLICATIONS / ADVERSE EVENTS. THIS MDR IS FOR THE CLOTTRIEVER CATHETER DEVICE. REFER TO MDR #3011525976-2022-00005 FOR THE OTHER INARI DEVICE INVOLVED IN THIS EVENT. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    A (B)(6)-YEAR-OLD MALE PATIENT WITH A RARE BLOOD CLOTTING DISORDER PRESENTED TO THE EMERGENCY DEPARTMENT IN UNSTABLE CONDITION WITH CLOTTING ABOVE HIS EXISTING INFERIOR VENA CAVA (IVC) FILTER. THE PATIENT ALSO HAD BILATERAL DEEP VEIN THROMBOSIS (DVT) IN BOTH LEGS. THE IVC FILTER WAS PLACED 9 DAYS PRIOR AND THE PATIENT UNDERWENT SPINAL SURGERY 5 DAYS PRIOR. THE COMPUTERIZED TOMOGRAPHY (CT) SCAN DID NOT SHOW A PULMONARY EMBOLISM. ANTICOAGULANT MEDICATION HAD BEEN DISCONTINUED SINCE THE TIME OF IVC FILTER PLACEMENT AND WAS NOT REINITIATED. THE TREATMENT PLAN WAS TO USE THE INARI FLOWTRIEVER 20 (T20) TO ADDRESS CLOTTING ABOVE AND IN THE IVC FILTER AND THEN USE THE INARI CLOTTRIEVER TO ADDRESS THE DVTS IN THE LEGS. AN ECHOCARDIOGRAM WAS NOT PERFORMED PRIOR TO THE PROCEDURE. AN ACTIVATED CLOTTING TIME (ACT) TEST WAS RUN AND THE ADVISING NEUROSURGEON REQUESTED LIMITING ANTICOAGULANTS. THE PATIENT WAS INTUBATED AND PLACED ON VASOPRESSORS. A 22 FR GORE DRYSEAL SHEATH WAS PLACED IN THE NECK AND AN 8 FR SHEATH WAS PLACED IN THE LEFT POPLITEAL VEIN. TWO INTERVENTIONAL RADIOLOGISTS WERE PRESENT, THE PRIMARY PHYSICIAN WAS ASSIGNED TO TREAT THE IVC CLOT WITH THE T20 AND THE SECOND PHYSICIAN PROVIDED ASSISTANCE AND ASSIGNED TO USE THE ANGIOJET TO TREAT THE DVTS IN THE LEFT EXTERNAL AND COMMON ILIAC. THE T20 WAS POSITIONED ABOVE THE IVC FILTER AND THE FIRST PASS YIELDED A LARGE AMOUNT OF CLOT. THREE SUBSEQUENT PASSES OF THE T20 WERE MADE BELOW AND IN THE FILTER. THE THIRD PASS CLEARED A LARGE AMOUNT OF PROCEDURAL CLOT. THE T20 WAS PULLED BACK AND FLUSHED. THE ACT READING WAS 116 AND HEPARIN WAS ADMINISTERED. IMAGING REVEALED CLOT RESOLUTION ABOVE THE FILTER, BUT REMAINING CLOT IN THE FILTER AND IVC. FIVE MORE ASPIRATIONS WERE PERFORMED WHICH ADDRESSED THE IVC AND ILIACS, BUT CLOT REMAINED IN THE FILTER. AN ATTEMPT WAS MADE USING THE ANGIOJET FROM BELOW THE IVC, ALONG WITH 2 MORE ASPIRATIONS FROM THE T20, BUT NONE YIELDED CLOT. THE PHYSICIANS CHANGED THE PLAN AND DECIDED TO USE THE INARI CLOTTRIEVER (CT) TO ADDRESS THE DVTS IN THE LEGS AFTER REMOVING THE FILTER USING A LONG SHEATH. A 16 FR LONG SHEATH WAS USED TO REMOVE THE IVC FILTER AND THE FLOWTRIEVER (FT) XL DISCS WERE DEPLOYED ABOVE IT IN THE IVC TO PROTECT FROM EMBOLIZATION. THE XL FT DISCS WERE PLACED FROM THE LEFT POPLITEAL THROUGH THE CT SHEATH. ONCE THE IVC FILTER WAS REMOVED FROM THE PATIENT, THERE WAS CLOT ADHERED TO THE FILTER. THE CT CATHETER WAS THEN INSERTED AND A SINGLE PASS WAS MADE. AT THIS TIME, THE ANESTHESIOLOGIST INFORMED THE TREATING PHYSICIANS THAT THE PATIENT WAS BECOMING UNSTABLE. THE PATIENT'S RIGHT GROIN WAS PREPPED, AND A CODE WAS INITIATED, CONTINUING FOR 21 MINUTES DURING WHICH TIME SYSTEMIC TPA WAS ADMINISTERED. ADDITIONALLY, THE PHYSICIAN PERFORMED 4 ASPIRATIONS IN THE LEFT LUNG AND RIGHT LOWER PULMONARY ARTERY, BUT ONLY 2 SMALL CLOTS WERE REMOVED. AFTER EXHAUSTING ALL POSSIBLE INTERVENTIONS, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WITH A HEART RATE (HR) OF 48 BPM, BLOOD PRESSURE (BP) OF 225/132 MMHG, AND 50% OXYGENATION SATURATION (SPO2). UNFORTUNATELY, THE PATIENT WAS UNABLE TO RECOVER AND LATER EXPIRED DURING THE EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2750762 CLOTTRIEVER CATHETER THROMBECTOMY SYSTEM QEW INARI MEDICAL, INC. 40-102 00850291007093

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Life Threatening| R| H| D ANGIOJET| CLOTTRIEVER SHEATH| FLOWTRIEVER XL| GORE DRYSEAL SHEATH 22 FR| LONG SHEATH 16 FR| SHEATH 8 FR| TRIEVER20