BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 11830709 · Received May 17, 2021

    Report

    Report Number
    9612164-2021-01915
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    March 31, 2021
    Report Date
    May 17, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL TITLE: STUMP LENGTH CHANGES AFTER ENDOVENOUS CYANOACRYLATE CLOSURE OR RADIOFREQUENCY ABLATION FOR SAPHENOUS VEIN INCOMPETENCE THE KOREAN SOCIETY FOR VASCULAR SURGERY VASC SPECIALIST INT 2021;37(1):14-21 ¿ HTTPS://DOI.ORG/10.5758/VSI.210006. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SEVENTY-ONE PATIENTS WERE INVOLVED IN A RETROSPECTIVE STUDY IN THE TREATMENT OF INCOMPETENT SAPHENOUS VEIN. THE AIM OF THE STUDY WAS TO ANALYZE THE CHANGES IN STUMP LENGTH OVER TIME. THE PATIENTS WERE DIVIDED INTO TWO TREATMENT GROUPS - CYANOACRYLATE CLOSURE (CAC) AND RADIOFREQUENCY ABLATION (RFA). VENASEAL OCCLUDING DEVICE WAS USED IN THE CAC GROUPS AND CLOSUREFAST ABLATION DEVICE USED IN THE RFA GROUP. THE GREAT SAPHENOUS VEIN (GSV), SHORT SAPHENOUS VEIN (SSV) AND PERFORATOR VEINS WERE THE VEINS TREATED. A TOTAL OF NINETY-SEVEN VEINS (64 GSVS AND 33 SSVS) WERE ANALYZED IN THE STUDY. THE CLINICAL OUTCOMES REPORTED ARE RECANALIZATION OF TREATED VEINS, ECCHYMOSIS, PHLEBITIS LIKE REACTION AND EGIT 2 (THROMBUS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732002 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention