BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    LIMFLOW EXTENSION STENT GRAFT, 5.5MM X 200MM

    MDR report key: 23785459 · Received December 11, 2025

    Report

    Report Number
    3023527320-2025-00008
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 12, 2025
    Report Date
    January 28, 2026
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QWN
    UDI-DI
    00850041730219
    PMA / PMN Number
    P220025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO BEING DISCARDED, ALTHOUGH IT WAS INITIALLY THOUGHT THAT THE DEVICE WOULD RETURN. THIS WAS CONFIRMED WITH THE ACCOUNT MANAGER PRESENT AT THE PROCEDURE. MANUFACTURER REFERENCE NUMBER: (B)(4). 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.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS IN TRANSIT TO THE MANUFACTURER. UPON RECEIPT OF THE DEVICE A FULL EVALUATION WILL BE COMPLETED. 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 REMOVE ALL PIECES OF THE DEVICE FROM THE PATIENT. THIS DID NOT RESULT IN ANY PATIENT HARM AND THE PROCEDURE WAS SUCCESSFUL.

    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 REMOVE ALL PIECES OF THE DEVICE FROM THE PATIENT. THIS DID NOT RESULT IN ANY PATIENT HARM AND THE PROCEDURE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139107 LIMFLOW EXTENSION STENT GRAFT, 5.5MM X 200MM STENT GRAFT, INFRAPOPLITEAL, VENOUS ARTERIALIZATION QWN INARI MEDICAL, INC. RGS-55200-US-24 82342297 00850041730219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown