BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIEVER24

    MDR report key: 23417084 · Received October 29, 2025

    Report

    Report Number
    3020347218-2025-00073
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 29, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00810123710096
    PMA / PMN Number
    K213402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 STRYKER MEDICAL AFFAIRS, WHO CONCLUDED THAT THE PATIENT'S HEMOPTYSIS WAS THE RESULT OF CATHETER PERFORATION. MANUFACTURER REFERENCE #: (B)(4). CARDIAC PERFORATION AND CARDIAC TAMPONADE ARE IDENTIFIED IN THE LABELING AS POSSIBLE ADVERSE EVENTS/COMPLICATIONS.

    Description of Event or Problem · 0

    A (B)(6) YEAR-OLD FEMALE WITH PULMONARY EMBOLISM UNDERWENT A THROMBECTOMY WITH INARI DEVICES. THE PHYSICIAN BEGAN BY WIRING TO THE LEFT SIDE. A BENTSON WIRE WAS USED TO SELECT A VESSEL WHICH ENDED UP BEING A MORE PROXIMAL BRANCH IN THE DISTAL MIDDLE LOBE. THE BENTSON WIRE WAS SWAPPED FOR AN AMPLATZ SUPERSTIFF AND THE TRIEVER24 (T24) WAS ADVANCED. UPON ADVANCING THE T24 THROUGH THE HEART, THE PHYSICIAN FELT THAT THE CATHETER SUDDENLY ADVANCED FORWARD. IMAGING WAS PERFORMED WHICH SHOWED THAT THE T24 HAD ADVANCED VERY DISTAL TO THE END OF THE WIRE. THE T24 WAS BACKED OUT INTO THE ENTRANCE AREA OF THE LEFT PULMONARY ARTERY WHEN THE PATIENT EXPERIENCED HEMOPTYSIS. AN ANGIOGRAM REVEALED A VESSEL PERFORATION IN THE WIRED BRANCH. BALLOONING WAS PERFORMED UNTIL THE BLEEDING HAD STOPPED. THE PERFORATION WAS ALSO EMBOLIZED WITH MULTIPLE COILS. THE PATIENT'S CONDITION IMPROVED ON THE TABLE AND FOLLOW-UP REVEALED THAT THE PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686688 TRIEVER24 PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 22-101 25060104 00810123710096

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female Life Threatening| R AMPLATZ SUPERSTIFF 1CM TAPER WIRE| BENTSON WIRE