BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 24675133 · Received March 24, 2026

    Report

    Report Number
    2183870-2026-00127
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    January 3, 2019
    Report Date
    March 24, 2026
    Manufacturer
    COVIDIEN
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REGRESSION OF VARICOSE VEINS AFTER CYANOACRYLATE CLOSURE OF INCOMPETENT GREAT SAPHENOUS VEINS WITHOUT A LOCALIZED CONCOMITANT PROCEDURE HWANG ET AL JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS COPYRIGHT 2018 BY THE SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC. HTTPS://DOI.ORG/10.1016/J.JVSV.2018.10.016. 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

    ABSTRACT OBJECTIVE: THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE EFFECTIVENESS AND SAFETY OF ENDOVENOUS CYANOACRYLATE CLOSURE (CAC) OF INCOMPETENT GREAT SAPHENOUS VEIN (GSV) AND TO ASSESS THE REGRESSION OF VARICOSE VEIN FOLLOWING CAC WITHOUT A CONCOMITANT PROCEDURE. METHODS: A TOTAL OF 63 LIMBS IN 48 PATIENTS TREATED WITH CAC BECAUSE OF AN INCOMPETENT GSV BETWEEN DECEMBER 2016 AND NOVEMBER 2017 WERE RETROSPECTIVELY EVALUATED. IN FIVE LIMBS, INCOMPETENT GSV AND SMALL SAPHENOUS VEIN WERE TREATED SIMULTANEOUSLY IN THE SAME SESSION. DUPLEX ULTRASOUND, VENOUS CLINICAL SEVERITY SCORE, DEGREE OF REGRESSION OF VARICOSE VEINS, AND ADVERSE EVENTS WERE EXAMINED AT INTERVALS OF 1 WEEK, 1 MONTH, 3 MONTHS, 6 MONTHS, AND 12 MONTHS. RESULTS: IN 63 LIMBS, OF WHICH 60 WERE AVAILABLE FOR FOLLOW-UP, ALL TREATED GSVS SHOWED COMPLETE CLOSURE DURING THE FOLLOW-UP PERIOD (8.4 6 3.0 MONTHS). VENOUS CLINICAL SEVERITY SCORES AT THE TIME OF ALL FOLLOW-UP VISITS WERE SIGNIFICANTLY LOWER (P <(><<)> .001) THAN THOSE BEFORE CAC. COMPLETE RESOLUTION OF VARICOSE VEINS WAS NOTED IN 38 LIMBS (71.7%) AFTER 3-MONTH FOLLOW-UP. THE PROPORTION OF LIMBS SHOWING >50% VARICOSE VEIN REGRESSION REACHED 90.6%. THE MORE THAT VARICOSITY ENTRY WAS COVERED (P ¼ .002) AND THE FARTHER DOWN THE LEG THE ACCESS SITE WAS LOCATED (P ¼ .024), THE MORE C COMPLETE RESOLUTION OF VARICOSE VEINS WAS OBSERVED. PHLEBITIS OCCURRED IN 10 LIMBS (16.7%), AND HYPERPIGMENTATION OCCURRED IN 8 LIMBS (13.3%). CONCLUSIONS: CAC IS SAFE AND EFFECTIVE FOR THE TREATMENT OF AN INCOMPETENT GSV. IT ALSO SHOWS A SATISFACTORY RESULT WITH THE REGRESSION OF VARICOSE VEINS. COVERING THE ENTRY OF VARICOSITIES AND ACCESSING LOWER DOWN THE LEG ARE ASSOCIATED WITH MORE COMPLETE RESOLUTION OF VARICOSE VEINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735418 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other