BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNUS CLOSURE

    MDR report key: 23448542 · Received November 3, 2025

    Report

    Report Number
    2647346-2025-00187
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    November 18, 2019
    Report Date
    November 3, 2025
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    GEI
    PMA / PMN Number
    K061373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE TITLE POST-PROCEDURAL COMPRESSION VS. NO COMPRESSION AFTER RADIOFREQUENCY ABLATION AND CONCOMITANT FOAM SCLEROTHERAPY OF VARICOSE VEINS: A RANDOMISED CONTROLLED NON-INFERIORITY TRIAL 1078-5884/ 2019 EUROPEAN SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER B.V. ALL RIGHTS RESERVED. HTTPS://DOI.ORG/10.1016/J.EJVS.2019.08.020 A2 AVERAGE AGE A3 MAJORITY GENDER 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

    OBJECTIVE: TO COMPARE POST-OPERATIVE COMPRESSION WITH NO COMPRESSION, AFTER RADIOFREQUENCY ENDOTHERMAL ABLATION (RFA) OF A TRUNCAL VARICOSE VEIN AND CONCOMITANT FOAM SCLEROTHERAPY OF THE TRIBUTARIES. METHODS: THIS PROSPECTIVE RANDOMISED CONTROLLED, NON-INFERIORITY TRIAL RECRUITED PATIENTS FROM TWO CENTRES IN (B)(6). PATIENTS WITH CLINICAL CLASS C2EC4 CHRONIC VENOUS DISEASE WERE RANDOMISED TO RECEIVE NO COMPRESSION AFTER THE OPERATION, OR TO RECEIVE COMPRESSION STOCKINGS CONTINUOUSLY FOR TWO DAYS, AND THEN, DURING THE DAYTIME FOR FIVE DAYS. IN FOLLOW UP VISITS, ADDITIONAL FOAM SCLEROTHERAPY WAS PERFORMED FOR SYMPTOMS OF DISTAL INCOMPETENCE. PATIENTS WERE FOLLOWED UP FOR SIX MONTHS. THE PRIMARY OUTCOME WAS OCCLUSION OF THE RFA TREATED TRUNCAL VEIN AT SIX MONTHS. SECONDARY OUTCOMES WERE RETURN TO FULL ACTIVITY WITHIN 14 DAYS, ABERDEEN VARICOSE VEIN QUESTIONNAIRE (AVVQ) SCORE, POST-OPERATIVE PAIN, NEED FOR PAINKILLERS, AND POSTPROCEDURAL COMPLICATIONS. RESULTS: OF 177 INCLUDED PATIENTS, 90 WERE ALLOCATED TO POST-OPERATIVE COMPRESSION AND 87 TO NO COMPRESSION. AT SIX MONTHS, BOTH GROUPS SHOWED 100% OCCLUSION RATES IN RFA TREATED TRUNCAL VEINS (95% CONFIDENCE INTERVAL 0.043E0.042). WITHIN 14 DAYS OF TREATMENT, FULL PHYSICAL ACTIVITY WAS ACHIEVED BY 87% OF THE COMPRESSION GROUP AND 81% OF THE NO COMPRESSION GROUP, (P ¼ .29). AT SIX MONTHS, THE AVVQ SCORES WERE COMPARABLE AND SIGNIFICANTLY IMPROVED IN BOTH GROUPS, COMPARED WITH BASELINE. PAIN SCORES WERE COMPARABLE BETWEEN GROUPS, IN DAY-TO-DAY ANALYSES, AND THEY WERE SIGNIFICANTLY LOWER IN BOTH GROUPS ON DAY 10, COMPARED WITH PRE-OPERATIVE PAIN CAUSED BY VARICOSE VEINS. ON AVERAGE, POST-OPERATIVE PAIN MEDICATION WAS USED FOR 2.3 DAYS AND FOR 2.8 DAYS IN THE COMPRESSION AND NO COMPRESSION GROUPS, RESPECTIVELY (P ¼ .28). COMPLICATIONS THROUGHOUT THE SIX MONTH FOLLOW UP WERE COMPARABLE BETWEEN GROUPS, ALTHOUGH SKIN RASH/ BLISTERS OCCURRED MORE OFTEN IN THE COMPRESSION GROUP (P ¼ .01). CONCLUSION: AFTER TREATING C2EC4 VARICOSE VEINS WITH RFA AND CONCOMITANT FOAM SCLEROTHERAPY, NO POSTOPERATIVE COMPRESSION WAS NON-INFERIOR TO POST-OPERATIVE COMPRESSION, IN TERMS OF SAFETY AND EFFICACY. CLINICALTRIALS.GOV IDENTIFIER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019090 VNUS CLOSURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI MDT PUERTO RICO OPERATIONS CO, MED REL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention