BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLOTTRIEVER XL CATHETER

    MDR report key: 19353756 · Received May 20, 2024

    Report

    Report Number
    3020347-2024-00026
    Event Type
    Death
    Date Received
    May 20, 2024
    Date of Event
    April 20, 2024
    Report Date
    May 20, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007277
    PMA / PMN Number
    K223210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 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 CASE WAS REVIEWED BY INARI'S CHIEF MEDICAL OFFICER, WHO CONCLUDED THAT THE PATIENT'S DEATH WAS THE RESULT OF TUMOR THROMBUS AND OCCLUSION OF THE IVC. THE DEVICE INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING CONTRAINDICATIONS: "NOT INTENDED FOR USE WITHOUT ANTICOAGULATION." AND "NOT INDICATED FOR THE REMOVAL OF PREDOMINANTLY FIBROUS, FIRMLY ADHERENT, OR CALCIFIED MATERIAL (E.G., ATHEROSCLEROTIC PLAQUE)." THE DEVICE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING WARNING STATEMENT: "AVOID USING EXCESSIVE FORCE TO ADVANCE OR RETRACT AGAINST RESISTANCE. IF EXCESSIVE RESISTANCE IS ENCOUNTERED, RETRACT, AND COLLAPSE THE COLLECTION BAG AND CORING ELEMENT INTO THE OUTER CATHETER AND REMOVE THE DEVICE. EXCESSIVE FORCE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE DEVICE OR VESSEL." MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    A 49-YEAR-OLD MALE WITH RENAL CELL CARCINOMA TUMOR, WAS GIVEN A 50% SURVIVAL RATE OVER THE NEXT 90 DAYS. THE PATIENT HAD DEEP VEIN THROMBOSIS (DVT) CLOT WHICH EXTENDED FROM THE BILATERAL POPLITEAL INTO THE INFERIOR VENA CAVA (IVC) WITH TUMOR THROMBUS EXTENDING FROM THE RIGHT RENAL VEIN. THE CASE BEGAN WITH THE PATIENT IN A SUPINE POSITION. ACCESS WAS OBTAINED WITHOUT ISSUE AND THE PROTRIEVE SHEATH WAS PLACED IN THE INTERNAL JUGULAR AND SECURED WITH A TEGADERM. A CLOTTRIEVER SHEATH 16FR., WAS PLACED IN BOTH POPLITEAL VEINS. THE CLOTTRIEVER BOLD CATHETER WAS ADVANCED INTO POSITION ON THE RIGHT AND SIX PASSES WERE PERFORMED WITH AN ADDITIONAL FOUR ASPIRATIONS. THIS REMOVED A LARGE AMOUNT OF THROMBUS WHICH HAD EXTENDED FROM THE FEMORAL VEIN INTO THE ILIAC. THE PHYSICIAN SWITCHED TO THE LEFT SIDE AND FOUR PASSES WERE PERFORMED WHICH ALSO YIELDED A LARGE CLOT HAUL. THE PHYSICIAN THEN MOVED TO THE IVC AND PERFORMED FOUR PASSES AND FIVE ASPIRATIONS WITH THE CLOTTRIEVER XL CATHETER (CTXL) WHICH REMOVED CHRONIC CLOT. A VENOGRAM WAS THEN PERFORMED WHICH REVEALED THROMBUS STILL PRESENT IN THE IVC CONFLUENCE. THE PHYSICIAN ELECTED TO MOVE TO MORE AGGRESSIVE PULLS WITH THE CTXL FURTHER INTO THE ILIAC. THE PROTRIEVE SHEATH WAS ALSO MOVED FROM THE INFRARENAL TO THE SUPRARENAL. ON THE THIRD PULL, THE CTXL WOULD NOT PULL THROUGH THE PROTRIEVE SHEATH. MULTIPLE TROUBLESHOOTING ATTEMPTS WERE MADE BEFORE THE PROTRIEVE SHEATH BEGAN TO SHOULDER. THE PROTRIEVE SHEATH WAS RE-POSITIONED WITH THE CTXL POSITIONED IN THE ILIAC AND AN ASPIRATION WAS PERFORMED. A CODE WAS CALLED, AND CARDIOPULMONARY COMPRESSIONS WERE CONDUCTED. PRESSERS AND TPA WERE ALSO GIVEN. THE PROTRIEVE WAS REMOVED FROM THE BODY WHILE THE CTXL REMAINED. LIFE SAVING MEASURES WERE PERFORMED FOR THE NEXT 26 MINUTES, BUT THE PATIENT UNFORTUNATELY DID NOT MAKE IT. THE CTXL WAS EVENTUALLY REMOVED UNDER EXTREME FORCE. EXAMINATION OF THE DEVICE REVEALED THREE SOLID SAUCED-SHAPED TUMOR CLOTS STICKING OUT OF THE COLLECTION BASKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993714 CLOTTRIEVER XL CATHETER PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 41-102 23080002 00850291007277

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Death CLOTTRIEVER BOLD| CLOTTRIEVER SHEATH 16FR| TEGADERM