BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIEVER20

    MDR report key: 19867122 · Received July 30, 2024

    Report

    Report Number
    3020347218-2024-00034
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 29, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    PMA / PMN Number
    K213402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TREIVER20 WAS RETURNED TO THE MANUFACTURER AND EVALUATED. THE PROXIMAL END OF THE CATHETER WAS RECEIVED WITH THE DILATOR INSIDE AND THE DISTAL SECTION OF THE CATHETER THAT HAD SEPARATED WAS ALSO RECEIVED. COIL DAMAGE AND LINER DELAMINATION WERE OBSERVED AT THE SEPARATION INTERFACE. AT THE DISTAL END OF THE SEPARATED PORTION OF THE CATHETER, SIGNIFICANT TIP DAMAGE AND A KINK THAT APPEARED CRUSHED WERE OBSERVED. ADDITIONALLY, A KINK AT APPROXIMATELY 25 INCHES FROM THE PROXIMAL END WAS ALSO OBSERVED. DAMAGE CONSISTENT WITH REMOVING THE CATHETER USING THE ENDOBRONCHIAL FORCEPS WAS ALSO NOTED ON THE CATHETER AND DILATOR. THE DAMAGED TIP AND KINKS ON THE CATHETER WERE LIKELY CAUSED BY EXCESSIVE FORCE USED TO ADVANCE THE CATHETER, POSSIBLY DUE TO ADVANCING THE DEVICE INTO VESSELS THAT MAY HAVE BEEN SMALLER THAN MEASURED AND POSSIBLY BY ADVANCING THE CATHETER "BAREBACK". USE WITHOUT A SHEATH CAN CAUSE EXTRA STRESS ON THE CATHETER AND KINKING IN THE CATHETER CAUSES A WEAK POINT AND THE CATHETER BECOMES MORE SUSCEPTIBLE TO BREAKAGE AT THE WEAK POINTS. THE DEVICE IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THERE ALSO HAVE BEEN NO SIMILAR COMPLAINT EVENTS FOR THIS LOT NUMBER. THE DEVICE LABELING STATES THE DEVICE IS CONTRAINDICATED FOR USE IN VESSELS < 6 MM. THE DEVICE LABELING RECOMMENDS THE USE OF A 22 FR INTRODUCER SHEATH WITH USE OF THE TREIVER20. THE DEVICE LABELING INCLUDES THE FOLLOWING WARNING STATEMENT: "DO NOT ADVANCE CATHETER WITHOUT DILATOR FULLY INSERTED. AVOID USING EXCESSIVE FORCE TO ADVANCE OR RETRACT AGAINST RESISTANCE. IF EXCESSIVE RESISTANCE OCCURS, RETRACT AND REMOVE THE DEVICE. EXCESSIVE FORCE AGAINST RESISTANCE OR ADVANCEMENT WITHOUT DILATOR FULLY INSERTED MAY RESULT IN DAMAGE TO THE DEVICE OR VESSEL PERFORATION." MANUFACTURER REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE IDENTIFIERS WERE NOT PROVIDED, HOWEVER, THE LOT HISTORY RECORDS OF ALL POTENTIAL LOTS SHIPPED TO THE FACILITY WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. ADDITIONALLY, A COMPLAINT HISTORY REVIEW WAS CONDUCTED FOR THE POTENTIAL LOTS, AND NO SIMILAR ISSUES HAVE BEEN REPORTED AGAINST THE LOT NUMBERS. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2024, A 13-YEAR-OLD FEMALE WITH LOWER LEFT EXTREMITY (LLE) DEEP VEIN THROMBOSIS (DVT) UNDERWENT DVT THROMBECTOMY USING INARI DEVICES. SHE PRESENTED AT THE HOSPITAL AFTER EXPERIENCING LLE SWELLING AND PAIN FOR ONE WEEK. THE CLOT AGE WAS ESTIMATED AT SEVEN DAYS. IN PREPARATION FOR THE DVT THROMBECTOMY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND INTUBATED. THE PATIENT WAS POSITIONED PRONE, AND THE POPLITEAL VEIN WAS ACCESSED VIA ULTRASOUND GUIDANCE WITH MICROPUNCTURE. THE INITIAL VENOGRAM CONFIRMED THE CLOT LOCATION AND THAT THE TEAM WAS IN THE NATIVE VEIN. INTRAVENOUS ULTRASOUND (IVUS) SHOWED THE PATIENT'S POPLITEAL VEIN UP TO HER COMMON FEMORAL VEIN RANGED ROUGHLY FROM 6MM TO 8MM. THE DECISION WAS MADE TO PROCEED WITH THE THROMBECTOMY USING AN INARI TREIVER20 CATHETER (T20). AN AMPLATZ SUPER STIFF GUIDEWIRE WAS PLACED IN THE INFERIOR VENA CAVA (IVC) AND THE ACCESS SITE WAS DILATED TO 20FR SUCCESSFULLY. MODERATE RESISTANCE WAS FELT AS THE T20 WAS INTRODUCED OVER THE GUIDEWIRE AND INTO THE PROXIMAL FEMORAL VEIN. TWO ASPIRATIONS WERE ATTEMPTED, HOWEVER THE CATHETER CAVITATED DURING EACH ATTEMPT. AFTER THE SECOND ASPIRATION ATTEMPT, AN EXTREME AMOUNT OF RESISTANCE WAS FELT AS THE DEVICE WAS RETRACTED. THE DILATOR WAS REINSERTED TO PROVIDE MORE SUPPORT AND RESISTANCE WAS FELT AGAIN AND AS THE DEVICE WAS WITHDRAWN A "SNAP" WAS HEARD, AND IT WAS APPARENT THE CATHETER HAD FRACTURED. FLUOROSCOPY REVEALED ROUGHLY 20CM OF DISTAL SEGMENT OF THE T20 UNRAVELED IN THE PATIENT, EXTENDING FROM THE PROXIMAL FEMORAL VEIN TO THE POPLITEAL VEIN. THE INNER CATHETER WIRE WAS CUT, AND THE DILATOR WAS REMOVED COMPLETELY. AN ATTEMPT WAS MADE TO PULL THE FRACTURED CATHETER SEGMENT OUT OF THE PATIENT'S BODY BY INSERTING AN 8MM BALLOON OVER THE WIRE, JUST PROXIMAL TO THE DISTAL TIP OF THE T20, HOWEVER THE ATTEMPT WAS UNSUCCESSFUL. THE PATIENT WAS THEN FLIPPED SUPINE, AND THE IPSILATERAL COMMON FEMORAL VEIN WAS ACCESSED WITH A 6FR SHEATH AND INTRAVENOUS NITROGLYCERINE WAS ADMINISTERED VIA THE COMMON FEMORAL SHEATH TO HELP WITH VESSEL DILATION. THE COMMON FEMORAL ACCESS SITE WAS UPSIZED TO THE 24FR DRY GORE SEAL SHEATH, AND THE MEDICAL TEAM WAS ABLE TO OVERSHEATH THE DISTAL TIP OF THE T20 CATHETER WITH THE DRY GORE SEAL SHEATH FROM ABOVE. THE FRACTURED SEGMENT OF THE T20 WAS THEN ABLE TO BE ENTIRELY REMOVED USING ENDOBRONCHIAL FORCEPS. A VENOGRAM WAS PERFORMED WHICH SHOWED NO VASCULAR INJURY TO THE PATIENT. A CLOTTRIEVER SHEATH, 16FR WAS THEN PLACED IN THE LEFT POPLITEAL VEIN AND FOUR PASSES USING THE CLOTTRIEVER BOLD WERE COMPLETED, APPROXIMATELY 90% OF THE CLOT WAS REMOVED. ALL DEVICES WERE REMOVED, AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199020 TRIEVER20 PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female AMPLATZ SUPER STIFF GUIDEWIRE