BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 6528500 · Received April 27, 2017

    Report

    Report Number
    3011410703-2017-00143
    Event Type
    Injury
    Date Received
    April 27, 2017
    Date of Event
    January 1, 2017
    Report Date
    March 29, 2017
    Manufacturer
    COVIDIEN
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AGE AT EVENT: MEAN AGE. DATE OF EVENT: ESTIMATE OF WHEN EVENTS BEGAN STUDY TITLE: VECLOSE TRIAL 12-MONTH OUTCOMES OF CYANOACRYLATE CLOSURE VERSUS RADIOFREQUENCY ABLATION FOR INCOMPETENT GREAT SAPHENOUS VEINS. AUTHOR: NICK MORRISON, MD, KATHLEEN GIBSON, MD, MICHAEL VASQUEZ, MD, ROBERT WEISS, MD, DANIEL CHER, MD, MONTE MADSEN, RVT, RPHS,F, ANDREW JONES, MD HTTP://DX.DOI.ORG/10.1016/J.JVSV.2016.12.005. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A STUDY WAS CONDUCTED TO EVALUATE THE OUTCOMES OF CYANOACRYLATE CLOSURE (CAC) WITH VENASEAL DEVICE VERSUS RADIOFREQUENCY (RF) ABLATION WITH CLOSUREFAST CATHETER FOR INCOMPETENT GREAT SAPHENOUS VEIN (GSV) CLOSURE. THERE WERE 222 PATIENTS WITH SYMPTOMATIC GSV INCOMPETENCE; 108 RECEIVED CAC AND 114 RF ABLATION. AVERAGE AGE OF CAC GROUP WAS 49 YEARS, AND RFA GROUP WAS 51 YEARS. FOLLOW UP DUPLEX ULTRASOUND WERE PERFORMED AT 3,6,12 MONTH INTERVALS. THE PATIENTS TREATED WITH VENASEAL PRESENTED WITH INFECTION AT THE ACCESS SITE, REOCCLUSION, RECANALISATION PATIENTS UNDERWENT PHLEBECTOMY AND SCLEROTHERAPY AND CHRONIC PHLEBITIS TREATED WITH NONSTEROIDAL ANTI-INFLAMMATORY DRUGS. THE PATIENTS TREATED WITH THE CLOSUREFAST CATHETER PRESENTED WITH INFECTION AT THE ACCESS SITE, REOCCLUSION, RECANALISATION, SUPERFICIAL PHLEBITIS AND HEAT INDUCED THROMBUS EXTENSION. THE STUDY CONCLUDED THAT BOTH CAC AND RFA TREATMENTS RESULT IN HIGH OCCLUSION RATES. TIME TO COMPLETE OCCLUSION WAS FASTER WITH CAC, AND FREEDOM FROM REOPENING WAS HIGHER AFTER CAC. QUALITY OF L IFE SCORES IMPROVED EQUALLY WITH BOTH THERAPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308867 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ COVIDIEN UNK-PLY-VENASEAL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention