BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 14929068 · Received July 6, 2022

    Report

    Report Number
    9612164-2022-02534
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    January 1, 2021
    Report Date
    July 6, 2022
    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    THE THERAPEUTIC EFFECT AND ADVERSE EVENTS OF CYANOACRYLATE CLOSURE (CAC) USING VENASEAL ON SAPHENOUS VARICOSE VEINS WERE EVALUATED USING DUPLEX ULTRASONOGRAPHY, SUBJECTIVE SYMPTOMS, AND PHYSICAL FINDINGS. WE ALSO REPORTED THE CHANGE OF THE PROXIMAL NON-OCCLUDED STOMP LENGTH OF THE SAPHENOUS VEIN WHEN THE DISTANCES FROM THE JUNCTION TO THE TIP OF THE DELIVERY CATHETER WERE 4CM AND 5CM. THIS STUDY INCLUDED 103 PATIENTS OF PRIMARY SAPHENOUS VARICOSE VEINS (GSV 107, SSV 15). THE OCCLUSION RATE OF THE SAPHENOUS VEIN BY CAC WAS 99.1% AT ONE MONTH, 97.6% AT THREE MONTHS, AND 97.6% AT ONE YEAR. REGURGITATION BLOCKING OF THE SAPHENOUS VEIN WAS OBSERVED IN ALL CASES. THE MOST COMMON COMPLICATION WAS PHLEBITIS, WHICH WAS 11.5% AND WAS MOST COMMON 16.5 DAYS AFTER SURGERY. OTHER COMPLICATIONS SUCH AS POLYMERIZED CYANOACRYLATE, THROMBUS EXTENSION TO THE DEEP VEIN, AND POLYMERIZED CYANOACRYLATE ADHERING TO THE JUNCTION WERE OBSERVED. NO COMPLICATIONS DUE TO VARICOSE VEIN RESECTION OR SCLEROTHERAPY WERE OBSERVED. THE INJECTION START POSITION WAS DIVIDED INTO A 4CM GROUP (37 VEINS) AND A 5CM GROUP (85 VEINS) FROM THE JOINT, AND THE STUMP LENGTHS WERE COMPARED, BUT NO SIGNIFICANT DIFFERENCE WAS OBSERVED. MORE DETAILED STUDIES ARE WARRANTED TO INVESTIGATE THE RELATIONSHIP BETWEEN STUMP LENGTH AND POST OPERATIVE BRANCH RECURRENCE. ACCUMULATION OF MULTICENTER TREATMENT EXPERIENCE AND LONG TERM FOLLOW UP IS REQUIRED. IN ADDITION, IT IS ESSENTIAL TO PERFORM CAC ON OUTPATIENT TO CONTRIBUTE TO THE REDUCTION OF MEDICAL EXPENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481357 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female