BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 22975565 · Received September 5, 2025

    Report

    Report Number
    9612164-2025-04389
    Event Type
    Injury
    Date Received
    September 5, 2025
    Report Date
    September 5, 2025
    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

    JAPAN SOCIETY OF PLASTIC SURGERY BASIC MEETING PROGRAM · ABSTRACTS. 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: TREATMENT OF VARICOSE VEINS BEGAN WITH STRIPPING AND HIGH LIGATION. INTRAVENOUS THERMAL ABLATION (ETA) REQUIRES TUMESCENT REGIONAL ANESTHESIA (TLA) AND IS ASSOCIATED WITH COMPLICATIONS SUCH AS PAIN AND SUBCUTANEOUS BLEEDING. CYANOACRYLATE CLOSURE (CAC) IS A MINIMALLY INVASIVE TREATMENT THAT DOES NOT REQUIRE TLA. PURPOSE: A NEW TECHNOLOGY USING CAC, THE VENASEAL CLOSURESYSTEM (MEDTRONIC, MINNEAPOLIS, USA ), WAS APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) IN 2015 IT WAS FIRST APPROVED BY AND HAS BEEN COVERED BY JAPAN HEALTH INSURANCE SINCE DECEMBER 2019. THE INDICATION IS SYMPTOMATIC PRIMARY VARICOSE VEINS. CONTRAINDICATIONS INCLUDE A HISTORY OF ALLERGY TO CYANOACRYLATE ADHESIVES. COMPLICATIONS OF CAC HAVE NOT YET BEEN WIDELY REPORTED DUE TO CLINICAL EXPERIENCE AND DATA ACCUMULATION. METHODS: VARICOSE VEINS FROM APRIL 2014 TRIPPING SURGERY, ETA SINCE JULY 2018, CAC SINCE JULY 2021. 137 LEGS (116 LARGE SAPHENOUS VEINS AND 39 SMALL SAPHENOUS VEINS) WERE STUDIED IN A RETROSPECTIVE STUDY OF CAC. RESULTS: POSTOPERATIVE COMPLICATIONS SUCH AS PHLEBITIS, ALLERGIES, AND INTRAVENOUS ADHESIVE-INDUCED THROMBOSIS (EGIT) WERE OBSERVED. HOWEVER, NO SERIOUS A DVERSE EVENTS WERE OBSERVED, SUCH AS DEEP VEIN THROMBOSIS (DVT) AND PULMONARY THROMBOEMBOLISM (PTE). ULTRASOUND EXAMINATIONS WERE PERFORMED AT 1 DAY, 1 MONTH, AND 3 MONTHS POSTOPERATIVELY. CONCLUSION (S): CAC IS ONE OF THE TREATMENTS FOR VARICOSE VEINS. WE REPORT THE DISCUSSION OF SOME RELATED LITERATURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263483 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention