BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 24494821 · Received March 3, 2026

    Report

    Report Number
    9612164-2026-01109
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    October 4, 2023
    Report Date
    March 3, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUTCOMES OF CYANOACRYLATE CLOSURE VERSUS RADIOFREQUENCY ABLATION FOR THE TREATMENT OF INCOMPETENT GREAT SAPHENOUS VEINS ANN VASC SURG 2024; 98: 309¿316 TTPS://DOI.ORG/10.1016/J.AVSG.2023.08.016 ©2023 ELSEVIER INC. ALL RIGHTS RESERVED. ANNALS OF VASCULAR SURGERY 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

    BACKGROUND: EVALUATION OF THE EFFICACY AND SAFETY OF CYANOACRYLATE CLOSURE (CAC) FOR TREATING INCOMPETENT GREAT SAPHENOUS VEINS (GSVS) COMPARED TO RADIOFREQUENCY ABLATION (RFA). METHODS: IN THIS PROSPECTIVE, RANDOMIZED CONTROLLED STUDY, 248 SYMPTOMATIC SUBJECTS WITH INCOMPETENT GSVS WERE ASSIGNED TO EITHER CAC OR RFA. THE PRIMARY END POINT, COMPLETE CLOSURE OF THE TARGET GSV, WAS DETERMINED USING A DUPLEX ULTRASOUND EXAMINATION. RESULTS: IN THIS STUDY, 248 PATIENTS (MEAN AGE 33.64 ± 8.06 YEARS INCLUDING 71% WOMEN) WERE TREATED WITH EITHER CAC (N = 128) OR RFA (N = 120) BETWEEN AUGUST 2018 TO MAY 2022. AS A FOLLOW-UP, AFTER A 1-MONTH DURATION, THE CLOSURE RATES WERE 128/128 AT THE CAC AND 154/158 AT THE RFA. AT MONTH 24, CLOSURE RATES WERE 122/128 AT CAC AND 146/158 AT RFA. APART FROM PHLEBITIS AND PIGMENTATION, THE INCIDENCES OF BRUISING, SKIN BURN, AND PARESTHESIA WERE LOWER IN THE CAC GROUP COMPARED TO THE RFA GROUP. THE MEAN PROCEDURAL TIMES WERE SHORTER FOR CAC. THE SATISFACTION LEVEL WITH THE TREATMENT WAS MODERATELY HIGHER AMONG CAC PATIENTS THAN RAF PATIENTS. CONCLUSIONS: THIS STUDY SUGGESTS THAT CYANOACRYLATE GLUE CLOSURE OF THE GSV AND RFA ARE EFFECTIVE TECHNIQUES FOR MANAGING PRIMARY VARICOSE VEINS. CYANOACRYLATE GLUE CLOSURE OF THE GSV APPEARS TO HAVE A LOWER RATE OF COMPLICATIONS AND HIGHER SATISFACTION LEVELS, RAPID RETURN TO NORMAL ACTIVITIES, AND IMPROVED PROCEDURE TIME WITHOUT THE NEED FOR PERIVENOUS TUMESCENT AN ESTHESIA AND POSTPROCEDURE COMPRESSION STOCKINGS WHEN COMPARED TO RFA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555231 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention