BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIMFLOW EXTENSION STENT GRAFT, 200MM

    MDR report key: 23709322 · Received December 3, 2025

    Report

    Report Number
    3023527320-2025-00007
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 3, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QWN
    UDI-DI
    00850041730219
    PMA / PMN Number
    P220025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LIMFLOW 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. ADDITIONALLY, A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND NO SIMILAR ISSUES HAVE BEEN REPORTED AGAINST THIS LOT NUMBER. THE DEVICE LABELING INCLUDES THE FOLLOWING INSTRUCTION: "5. ENSURE THE DELIVERY SYSTEM IS PINNED TO A FLAT SURFACE AND IS AS STRAIGHT AS POSSIBLE OUT OF THE FEMORAL SHEATH. CAUTION: ANY SLACK IN THE STENT SYSTEM (OUTSIDE THE PATIENT) COULD RESULT IN DEPLOYMENT CHALLENGES." MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT TRANSCATHETER ARTERIALIZATION OF DEEP VEIN (TADV) USING LIMFLOW DEVICES. THE LIMFLOW EXTENSION STENT GRAFT, 200MM (RGS-55200-US-24) PARTIALLY DEPLOYED A STENT, REQUIRING THE PHYSICIAN TO DISASSEMBLE THE DEVICE HANDLE AND FINISH THE DEPLOYMENT MANUALLY. THIS DID NOT RESULT IN ANY PATIENT HARM AND THE PROCEDURE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2854424 LIMFLOW EXTENSION STENT GRAFT, 200MM STENT GRAFT, INFRAPOPLITEAL, VENOUS ARTERIALIZATION QWN INARI MEDICAL, INC. RGS 82342297 00850041730219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown