BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUENCY PLUS ENDOVASCULAR STENT GRAFT

    MDR report key: 23035063 · Received September 12, 2025

    Report

    Report Number
    2020394-2025-01476
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 26, 2025
    Report Date
    September 24, 2025
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    PFV
    PMA / PMN Number
    P130029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL INFORMATION WAS RECEIVED AND THERE IS NO ALLEGED DEFICIENCY OR MALFUNCTION WITH THE PRODUCT. THIS REPORT IS NO LONGER BEING CONSIDERED A COMPLAINT FILE AND DETERMINED TO BE NO LONGER REPORTABLE. SINCE AN INITIAL MDR WAS SUBMITTED, THEREFORE, THE FILE WILL REMAIN ASSESSED AS A SERIOUS INJURY. G3. SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE. DURING DEPLOYMENT, IT WAS REPORTED THAT THE STENT DID NOT FULLY. IT WAS ALSO REPORTED THAT THE PATIENT HAD PAIN, SWELLING AND HEMATOMA. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE. DURING DEPLOYMENT, IT WAS REPORTED THAT THE STENT DID NOT FULLY. IT WAS ALSO REPORTED THAT THE PATIENT HAD PAIN, SWELLING AND HEMATOMA. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2676497 FLUENCY PLUS ENDOVASCULAR STENT GRAFT ENDOVASCULAR STENT GRAFT PFV BARD PERIPHERAL VASCULAR, INC. ANJY3625

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention