BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 24186879 · Received January 27, 2026

    Report

    Report Number
    9612164-2026-00475
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    May 29, 2025
    Report Date
    January 27, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL OUTCOMES OF CYANOACRYLATE CLOSURE VERSUS RADIOFREQUENCY ABLATION FOR SAPHENOUS VARICOSE VEINS: A SINGLECENTER RETROSPECTIVE STUDY WILEY INTERNATIONAL JOURNAL OF VASCULAR MEDICINE VOLUME 2025, ARTICLE ID 9668464, 7 PAGES HTTPS://DOI.ORG/10.1155/IJVM/9668464 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

    MEDTRONIC RECEIVED A LITERATURE ARTICLE TITLED 'CLINICAL OUTCOMES OF CYANOACRYLATE CLOSURE VERSUS RADIOFREQUENCY ABLATION FOR SAPHENOUS VARICOSE VEINS: A SINGLECENTER RETROSPECTIVE STUDY'. THE ARTILCE REPORTS A RETROSPECTIVE, SINGLE-CENTER STUDY CONDUCTED WITH 157 PATIENTS (178 LIMBS) WHO UNDERWENT EITHER CAC (VENASEAL CLOSURE SYSTEM) (N = 96) OR RFA (CLOSUREFAST CATHETER) (N = 82) FROM JANUARY 2020 TO OCTOBER 2023. PHLEBITIS OCCURRED IN 14 PATIENTS (15%) IN THE CAC GROUP, WHEREAS NO CASES WERE REPORTED IN THE RFA GROUP. PHLEBITIS WAS OBSERVED AS EARLY AS POSTOPERATIVE DAY 2 IN TWO PATIENTS, WHILE THE MAJORITY (12 PATIENTS) DEVELOPED SYMPTOMS AFTER 1 WEEK. REGARDING THROMBOTIC EVENTS, EGIT/EHIT CLASS 2 WAS OBSERVED IN ONE PATIENT (1%) IN BOTH GROUPS, BUT NO CASES OF CLASS 3 OR HIGHER WERE REPORTED. NO PATIENTS REQUIRED ANTICOAGULATION THERAPY. THE OCCLUSION RATE AT 3 MONTHS POSTOPERATIVELY WAS 100% IN BOTH CAC AND RFA GROUPS. OTHER COMPLICATIONS INCLUDED PARESTHESIA IN ONE PATIENT (1%) IN THE RFA GROUP, WHICH RESOLVED AFTER 1 YEAR, AND ULCER FORMATION IN ONE PATIENT (1%) IN THE RFA GROUP. NO CASES OF PARESTHESIA OR ULCERS WERE OBSERVED IN THE CAC GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249955 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND UNK-PLY-VENASEAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention