BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNUS CLOSURE

    MDR report key: 23579218 · Received November 18, 2025

    Report

    Report Number
    2183870-2025-00532
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    January 23, 2015
    Report Date
    November 18, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A RANDOMISED CONTROLLED TRIAL COMPARING COMPRESSION THERAPY AFTER RADIOFREQUENCY ABLATION FOR PRIMARY GREAT SAPHENOUS VEIN INCOMPETENCE PHLEBOLOGY. 2016 MAR;31(2):118-24. DOI: 10.1177/0268355514568658. EPUB 2015 JAN 23. PMID: 25616874. B3 DATE OF PUBLICATION MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    BACKGROUND: OPTIMAL DURATION OF LEG COMPRESSION AFTER VENOUS ABLATION REMAINS UNCLEAR. THIS RANDOMISED CONTROLLED TRIAL EVALUATES 4 H COMPARED TO 72 H OF LEG COMPRESSION. METHODS: PATIENTS WERE RANDOMISED TO 4 OR 72 H OF LEG COMPRESSION AFTER RADIOFREQUENCY ABLATION OF THE GREAT SAPHENOUS VEIN. PRIMARY OUTCOME WAS CHANGE IN LEG VOLUME AFTER 14 DAYS. SECONDARY OUTCOMES WERE POSTOPERATIVE PAIN, COMPLICATIONS AND TIME TO FULL RECOVERY. RESULTS: PATIENTS WEARING COMPRESSION STOCKINGS FOR 4 H AFTER TREATMENT HAD A 64 ML (95%CI: - 23 TO + 193) REDUCTION IN LEG VOLUME, COMPARED TO AN INCREASE OF 21 ML (95%CI: 8.33-34.5) IN PATIENTS WEARING COMPRESSION STOCKINGS FOR 72 H (P = 0.12). PATIENTS WEARING COMPRESSION STOCKINGS FOR 4 H EXPERIENCED FEWER COMPLICATIONS (16% VS. 33%, P = 0.05). POSTOPERATIVE PAIN AND TIME TO FULL RECOVERY DID NOT DIFFER SIGNIFICANTLY. CONCLUSION: WEARING COMPRESSION STOCKINGS FOR 4 H IS NON-INFERIOR IN PREVENTING LEG OEDEMA AS WEARING COMPRESSION STOCKINGS FOR 72 H. PRODUCTS MENTIONED: VNUS CLOSUREFAST COMPLICATION REPORTED BLISTER, SKIN IRRITATION, PARESTHESIA, THROMBOPHLEBITIS, HEMATOMA, WOUND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316919 VNUS CLOSURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention