BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 23579783 · Received November 18, 2025

    Report

    Report Number
    2183870-2025-00534
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    May 4, 2023
    Report Date
    November 18, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HYBRID ENDOVENOUS LASER ABLATION REDUCES THE RECURRENCE OF VARICOSE VEINS BELOW THE KNEE COMPARED WITH RADIOFREQUENCY ABLATION: A REAL-WORLD STUDY ARCH MED SCI 2023; 19 (6): 1739¿1746 DOI: HTTPS://DOI.ORG/10.5114/AOMS/163449 COPYRIGHT © 2023 TERMEDIA & BANACH 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

    INTRODUCTION: THIS STUDY AIMED TO INVESTIGATE THE OUTCOME OF HYBRID ENDOVENOUS LASER ABLATION (EVLA, 1470 NM) AND RADIOFREQUENCY ABLATION (RFA) PROCEDURES FOR VARICOSE VEINS (VVS). MATERIAL AND METHODS: WE RETROSPECTIVELY ANALYSED THE CLINICAL DATA OF PATIENTS FROM JULY 2019 TO DECEMBER 2020. EIGHTY-FOUR PATIENTS (121 LIMBS) UNDERWENT A HYBRID EVLA PROCEDURE, AND 108 PATIENTS (151 LIMBS) UNDERWENT AN RFA PROCEDURE. THE OUTCOMES, VENOUS CLINICAL SEVERITY SCORE (VCSS), CHRONIC VENOUS DISEASE QUALITY-OF-LIFE QUESTIONNAIRE (CIVIQ-20) SCORE, AND RECURRENCE AT 1, 6, AND 12 MONTHS WERE COLLECTED. RESULTS: NO DIFFERENCES IN COMPLICATIONS OR 24-H PAIN SCORES WERE NOTED BETWEEN THE 2 PROCEDURES, BUT A LOWER DOSAGE OF FOAM SCLEROSANT WAS USED IN THE EVLA PROCEDURE THAN IN THE RFA PROCEDURE (P 0.02). THE POSTOPERATIVE VCSS AND CIVIQ-20 SCORES IN THE 2 GROUPS WERE SIGNIFICANTLY DECREASED COMPARED WITH THE SCORES BEFORE THE PROCEDURE, AND NO DIFFERENCES IN SCORES WERE NOTED BETWEEN THE 2 PROCEDURES AT 1 MONTH. HOWEVER, THE VCSS AND CIVIQ-20 SCORES FOR THE EVLA PROCEDURE WERE SIGNIFICANTLY BETTER THAN THOSE FOR THE RFA PROCEDURE AT 6 AND 12 MONTHS (P 0.05). BOTH PROCEDURES SHOWED A SIMILAR GREAT SAPHENOUS VEIN CLOSURE RATE AT 12 MONTHS. THE EVLA PROCEDURE SHOWED LOWER RATES OF OVERALL RECURRENCE (4.96% VS. 14.57%, OR = 3.27, 95% CI: 1.33¿8.00, P = 0.01) AND RECURRENCE BELOW THE KNEE (4.13% VS. 11.92%, OR = 3.14; 95% CI: 1.18¿8.35, P = 0.02). MOREOVER, THE PATIENT SATISFACTION SCORE WAS GREATER FOR THE EVLA PROCEDURE THAN FOR THE RFA PROCEDURE (P 0.02). CONCLUSIONS: THE HYBRID EVLA (1470 NM) PROCEDURE REDUCES VV RECURRENCE BELOW THE KNEE AND RESULTS IN BETTER QUALITY-OF-LIFE SCORES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862817 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention