BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 14928956 · Received July 6, 2022

    Report

    Report Number
    9612164-2022-02533
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE TITLE CYANOACRYLATE CLOSURE WITH VENASEAL CLOSURE SYSTEM WAS EFFECTIVE FOR TREATING VARICOSE VEIN PATIENT WITH INCOMPETENT SMALL SAPHENOUS VEIN ANNALS OF VASCULAR DISEASES. AGE: AVERAGE AGE. GENDER: MAJORITY GENDER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IN (B)(6), CYANOACRYLATE CLOSURE (CAC) HAS BEEN INTRODUCED AS LESS INVASIVE TREATMENT OF INCOMPETENT SAPHENOUS VEINS. VENASEAL CLOSURE SYSTEM (VSCS) WAS APPROVED BY NATIONAL HEALTH INSURANCE. INCOMPETENT SMALL SAPHENOUS VEINS (SSV) ARE THOUGHT TO BE A GOOD INDICATION FOR VSCS, SINCE IT IS A NON-THERMAL NON-TUMESCENT (NTNT) TREATMENT WITHOUT ANY RISKS FOR SURROUNDING NERVE INJURY. HOWEVER, RCTS USING VSCS HAVE BEEN LIMITED TO THE PATIENTS WITH INCOMPETENT GREAT SAPHENOUS VEINS. HERE, THE RESULTS OF RETROSPECTIVE STUDY OF CAC WITH VSCS FOR THE TREATMENT OF INCOMPETENT SSV ARE REPORTED A SINGLE-CENTER EXPERIENCE. FROM FEB 2020 TO MAY 2021, VSCS WAS USED IN 51 LIMBS FOR THE TREAT OF SYMPTOMATIC VARICOSE VEINS PATIENTS. AMONG THOSE, 8 LIMBS HAD INCOMPETENT SSV, WITH C2-C4B. TREATMENT WITH VSCS WAS DONE BY DAY SURGERY UNDER LOCAL ANESTHESIA, WITHOUT CONCOMITANT PHLEBECTOMY. THE PATIENTS WERE ALLOWED NOT TO UNDERGO POSTOPERATIVE COMPRESSION THERAPY WITH ELASTIC STOCKINGS. DUPLEX ULTRASOUND (DUS) WAS PERFORMED AT DAY, DAY 7, MONTH 1, MONTH 3, AND YEAR 1 AFTER THE OPERATION FOR EVALUATION OF THE TREATED VEINS. AVERAGE OPERATION TIME WAS 28.8 +/- 6.9 MIN. CLOSURE RATE OF THE TREATED VEIN AT DAY 1, DAY 7, AND MONTH 1 WAS 100%. POSTOPERATIVE FOLLOW UP PERIOD RANGES FROM 1-12 MONTHS IN 8 LIMBS AND NO RECANALIZATION WAS OBSERVED SO FAR. AS POST OPERATIVE ADVERSE EVENTS, VTE WAS NOT OBSERVED. POSTOPERATIVE PHLEBITIS OR HYPERSENSITIVITY REACTION WAS NOT OBSERVED EITHER. IN 2 LIMBS, EHIT 3 WAS OBSERVED AT DAY 7 AND MONTH 3 POST OPERATIVELY AND WAS SUCCESSFULLY TREATED WITH A NTI-COAGULATION USING DIRECT ORAL ANTICOAGULANT. CAC WITH VSCS WAS EFFECTIVE TREATED FOR THE PATIENTS WITH INCOMPETENT SSV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421702 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention