BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 24256279 · Received February 4, 2026

    Report

    Report Number
    9612164-2026-00623
    Event Type
    Injury
    Date Received
    February 4, 2026
    Date of Event
    April 7, 2025
    Report Date
    February 4, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RETROSPECTIVE STUDY OF HYPERSENSITIVITY REACTIONS IN PATIENTS UNDERGOING CYANOACRYLATE CLOSURE OF LOWER EXTREMITY SUPERFICIAL VEINS 2025 THE AUTHOR(S). PUBLISHED BY ELSEVIER INC. ON BEHALF OF THE SOCIETY FOR VASCULAR SURGERY. THIS IS AN OPEN ACCESS ARTICLE UNDER THE CC BY-NC-ND LICENSE (HTTP://CREATIVECOMMONS.ORG/LICENSES/BY-NC-ND/4.0/). JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS JULY 2025 HTTPS://DOI.ORG/10.1016/J.JVSV.2025.102246 A2 AVERAGE AGE A3 MAJORITY SEX 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: CHRONIC VENOUS INSUFFICIENCY AFFECTS MORE THAN 25 MILLION ADULTS IN THE UNITED STATES, WHO INITIALLY PRESENTS WITH VARICOSE VEINS. ALTHOUGH THERMAL-BASED, MINIMALLY INVASIVE ENDOVENOUS PROCEDURES EXIST, THERE HAS BEEN A RECENT ADVENT OF NON-THERMAL ENDOVENOUS METHODS FOR VEIN ABLATION SUCH AS CYANOACRYLATE CLOSURE (CAC) WITH THE VENASEAL CLOSURE SYSTEM, WHICH DECREASES THE RISK OF THERMAL INJURY. THIS STUDY AIMED TO DETERMINE THE INCIDENCE, ONSET, DURATION, AND SEVERITY OF HYPERSENSITIVITY REACTIONS (HSRS) FOLLOWING CAC, AS WELL AS IDENTIFY RISK FACTORS FOR THE DEVELOPMENT OF HSRS. METHODS: THIS STUDY WAS CONDUCTED AT THE MASSACHUSETTS GENERAL BRIGHAM HEALTH CARE SYSTEM AND INCLUDED 122 PATIENTS WITH 193 VEINS TREATED BETWEEN 2018 AND 2022. PATIENTS AGED 18 YEARS AND OLDER WITH SYMPTOMATIC, INCOMPETENT SUPERFICIAL LOWER EXTREMITY VEINS, INCLUDING THE GREAT SAPHENOUS VEIN, SMALL SAPHENOUS VEIN, AND ANTERIOR ACCESSORY SAPHENOUS VEIN, WERE INCLUDED. DATA ON PATIENT DEMOGRAPHICS, CLINICAL HISTORY, PROCEDURE DETAILS, AND POST-PROCEDURAL DUPLEX ULTRASOUND RESULTS WERE COLLECTED. RESULTS: IN THIS COHORT, THE INCIDENCE OF HSRS WAS 21.2%. SYMPTOM ONSET OCCURRED ON AVERAGE 7.6 DAYS POST-PROCEDURE (STANDARD DEVIATION, 7.4 DAYS) WITH MOST PATIENTS EXPERIENCING MILD (76%) OR MODERATE (24%) SYMPTOMS THAT RESOLVED WITHOUT INTERVENTION, WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS, OR WITH STEROID TREATMENT. THERE WAS A SIGNIFICANTLY HIGHER RISK OF HSRS WITH YOUNGER AGE (P ¼ .0372), FEMALE SEX (P ¼ .0025), AND HISTORY OF ALLERGIES (P ¼ .0049). LONGER VEINS (P ¼ .0205) AND GREATER SAPHENOUS VEINS (P ¼ .0388) HAD STRONGER ASSOCIATIONS WITH HSRS. THE OVERALL POSTOPERATIVE CLOSURE RATE AFTER CAC PROCEDURE WAS 99.5%, WITHOUT A SIGNIFICANT DIFFERENCE BETWEEN PATIENTS WITH AND WITHOUT HSRS. CONCLUSIONS: HSRS ARE A POTENTIAL ADVERSE COMPLICATION OF THE CAC PROCEDURE, WITH MOST CASES BEING SELF-LIMITED AND AFFECTING INDIVIDUALS WHO ARE YOUNGER, ARE FEMALE, AND HAVE A HISTORY OF ALLERGIES. THESE FINDINGS SUGGEST THE NEED FOR CAREFUL PATIENT SELECTION AND COUNSELING DURING CONSIDERATION OF THE CAC PROCEDURE FOR THE TREATMENT OF CHRONIC VENOUS INSUFFICIENCY. (J VASC SURG VENOUS LYMPHAT DISORD 2025;13:102246.).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319221 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention