BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIMFFLOW STENT GRAFT SYSTEM

    MDR report key: 21694776 · Received March 26, 2025

    Report

    Report Number
    3023527320-2025-00003
    Event Type
    Injury
    Date Received
    March 26, 2025
    Date of Event
    February 26, 2025
    Report Date
    March 13, 2025
    Manufacturer
    LIMFLOW INC
    Product Code
    QWN
    PMA / PMN Number
    P220025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED. THERE HAVE BEEN NO SIMILAR COMPLAINT EVENTS FOR THIS LOT NUMBER. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE (ARC) IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED BY CONFLUENT MEDICAL TECHNOLOGIES. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THERE HAVE BEEN NO SIMILAR COMPLAINT EVENTS FOR THIS LOT NUMBER. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND EVALUATED. EVALUATION OF THE COMPLAINT DEVICE IDENTIFIED THE 150MM SGS APPEARED TO BE MOSTLY IN-TACT WITHOUT THE STENT. THE INNER POLYIMIDE WAS OBSERVED TO BE SLIGHTLY BENT. THE ROOT CAUSE OF THIS ISSUE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS A POSSIBILITY THAT DEVICES WERE BENT WHILE IN USE, CAUSING TENSION IN THE SYSTEM, RESULTING IN INABILITY TO DEPLOY THE STENTS. HOWEVER, THIS CANNOT BE VERIFIED AS THE DEVICE ONLY DEMONSTRATED A SLIGHT BEND.

    Description of Event or Problem · 0

    THE 2ND STENT USED IN THE PROCEDURE (150MM, LOT 900148) HAD ISSUES DEPLOYING ROUGHLY ABOUT 5 CM. IT WAS TRACKED TO THE LANDING POINT BELOW THE ANKLE. THE SYSTEM WAS IN A STRAIGHT CONFIGURATION. IT STARTED TO DEPLOY THEN IT STOPPED. THE PHYSICIAN DID NOT WANT TO DEPLOY THE STENT MANUALLY AND TRIED TO REMOVE IT FROM THE PATIENT. THIS WAS UNSUCCESSFUL AS THE STENT ENDED UP DEPLOYING ABOVE THE ANASTOMOSIS. THE PHYSICIAN THEN DECIDED TO PERFORM TWO VASCULAR CUTDOWNS TO REMOVE THE STENT. THE PHYSICIAN DECIDED TO COMPLETE THE PROCEDURE WITH VIABAHN.

    Description of Event or Problem · 0

    THE 2ND STENT USED IN THE PROCEDURE (150MM, LOT 900148) HAD ISSUES DEPLOYING ROUGHLY ABOUT 5 CM. IT WAS TRACKED TO THE LANDING POINT BELOW THE ANKLE. THE SYSTEM WAS IN A STRAIGHT CONFIGURATION. IT STARTED TO DEPLOY THEN IT STOPPED. THE PHYSICIAN DID NOT WANT TO DEPLOY THE STENT MANUALLY AND TRIED TO REMOVE IT FROM THE PATIENT. THIS WAS UNSUCCESSFUL AS THE STENT ENDED UP DEPLOYING ABOVE THE ANASTOMOSIS. THE PHYSICIAN THEN DECIDED TO PERFORM TWO VASCULAR CUTDOWNS TO REMOVE THE STENT. THE PHYSICIAN DECIDED TO COMPLETE THE PROCEDURE WITH VIABAHN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2100123 LIMFFLOW STENT GRAFT SYSTEM LIMFLOW SYSTEM, LIMFLOW CROSSING STENT GRAFT, LIMFLOW EXTENSION STENT GRAFT QWN LIMFLOW INC SGH-55150-US-21 900148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention