BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIMFLOW EXTENSION STENT GRAFT

    MDR report key: 23328461 · Received October 17, 2025

    Report

    Report Number
    3023527320-2025-00005
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    October 10, 2025
    Report Date
    January 14, 2026
    Manufacturer
    LIMFLOW INC.
    Product Code
    QWN
    UDI-DI
    00850041730219
    PMA / PMN Number
    P220025
    Adverse Event
    Yes
    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 IS IN TRANSIT TO THE MANUFACTURER. UPON RECEIPT OF THE DEVICE A FULL EVALUATION WILL BE COMPLETED. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE STENT GRAFT DELIVERY SYSTEM WAS RETURNED TO THE MANUFACTURER AND EVALUATED. VISUAL INSPECTION REVEALED THAT THERE WAS AN EXTREME HYPOTUBE BEND WHICH FRACTURED. CORRECTIVE ACTION WAS OPENED TO FURTHER INVESTIGATE AND DETERMINE POTENTIAL ROOT CAUSE. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025 DURING A LIMFLOW PROCEDURE, THE MEDICAL TEAM EXPERIENCED ISSUES WITH UNSUCCESSFUL STENT DEPLOYMENTS. AFTER ONE STENT GRAFT SYSTEM NOT DEPLOYING, A SECOND SYSTEM WAS USED. THE SECOND STENT GRAFT SYSTEM DEPLOYED APPROXIMATELY ONE THIRD OF THE WAY BEFORE IT STOPPED DEPLOYING. THE PHYSICIAN ACCESSED THE INSIDE OF THE HANDLE TO ATTEMPT TO MANUALLY DEPLOY THE REST OF THE STENT. WHEN THIS WAS UNSUCCESSFUL, THE PHYSICIAN DECIDED TO PULL THE ENTIRE SYSTEM FROM THE PATIENT RESULTING IN THE STENT STRETCHING AND EXTENDING PAST THE ANASTOMOSIS WITH THE POTENTIAL OF OCCLUDING OTHER VESSELS. TO PREVENT POTENTIAL ACUTE ISCHEMIA, THE PHYSICIAN PROCEEDED WITH FENESTRATING THE STRETCHED STENT PORTIONS ALONG BIFURCATING ARTERIAL VESSELS. ADDITIONALLY, THE STRETCHED PORTIONS OF THE STENT WERE RELINED WITH OTHER STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2737862 LIMFLOW EXTENSION STENT GRAFT STENT GRAFT, INFRAPOPLITEAL, VENOUS ARTERIALIZATION QWN LIMFLOW INC. RGS-55200-US-24 82336416 00850041730219

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention