BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIOFREQUENCY GENERATOR

    MDR report key: 8439182 · Received March 21, 2019

    Report

    Report Number
    2183870-2019-00141
    Event Type
    Injury
    Date Received
    March 21, 2019
    Date of Event
    January 14, 2019
    Report Date
    March 21, 2019
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K040638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE TITLE: TWELVE-MONTH EFFICACY AND COMPLICATIONS OF CYANOACRYLATE EMBOLIZATION COMPARED WITH RADIOFREQUENCY ABLATION FOR INCOMPETENT GREAT SAPHENOUS VEINS COPYRIGHT 2018 BY THE SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC. HTTPS://DOI.ORG/10.1016/J.JVSV.2018.10.019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INTRODUCTION: IN THIS STUDY, THE CLINICAL RESULTS OF RADIOFREQUENCY ABLATION (RFA) AND N-BUTYL-CYANOACRYLATE EMBOLIZATION (CAE) METHODS WERE COMPARED IN THE TREATMENT OF INCOMPETENT GREAT SAPHENOUS VEINS (GSVS). THE LATTER METHOD EMPLOYED THE NEW CA EMBOLIZATION SYSTEM, VENABLOCK (INVAMED, ANKARA, TURKEY). METHODS: THIS INDEPENDENT RETROSPECTIVE STUDY INCLUDED 244 PATIENTS (128 PATIENTS RFA, 116 PATIENTS CAE) WITH INCOMPETENT GREAT SAPHENOUS VEINS (GSVS) WHO APPLIED TO ESKISEHIR OSMANGAZI UNIVERSITY HOSPITAL OF FACULTY OF MEDICINE, CARDIOVASCULAR SURGERY CLINIC, BETWEEN JUNE 2013 AND JUNE 2016 AND WERE TREATED WITH RFA OR CAE. NO ADDITIONAL PROCEDURES, SUCH AS MINIPHLEBECTOMY OR SCLEROTHERAPY, WERE PERFORMED. ALL PATIENTS TREATED WITH RFA UNDERWENT SPINAL OR GENERAL ANESTHESIA IN THE CORONARY SURGERY OPERATING ROOM. PUNCTURE WAS PERFORMED WITH SELDINGER TECHNIQUE ON THE VSM FROM AN APPROPRIATE AREA AT KNEELEVEL UNDER ULTRASOUND GUIDANCE, AND A 7F SHEATH WAS PLACED. THE RFA APPLICATOR WAS PASSED THROUGH THE SHEATH UNDER ULTRASOUND GUIDANCE. THE EXTREME END OF THE CATHETER WAS CARRIED FORWARD ABOUT 2 CM DISTAL OF THE SFJ. AN AVERAGE OF 320 ML TA WAS APPLIED TO ALL PATIENTS. COVIDIEN CLOSURERFG RADIOFREQUENCY GENERATOR AND COVIDIEN CLOSUREFASTENDOVENOUS RFA CATHETER WERE USED. THE PROCEDURE WAS COMPLETED BY ABLATING 15 SECONDS AT 120C ON EACH 7-CM SEGMENT AT KNEE LEVEL. RESULTS: A TOTAL OF 244 PATIENTS WITH LOWER EXTREMITY VENOUS INSUFFICIENCY WERE ENROLLED IN THE STUDY. THE AVERAGE AGE WAS 46.30 YEARS IN THE RFA GROUP AND 49.21 YEARS IN THE CAE GROUP. NO OTHER CHARACTERISTICS WERE NOTED EXCEPT RHEUMATOID ARTHRITIS (N=1), PSORIATIC ARTHRITIS (N=3), PSORIASIS (N 5), MALIGNANCY (N=1), HYPERTENSION (N=19), AND DIABETES (N=13) IN THE PATIENTS¿ HISTORY. SKIN BURN, WHICH WE CONSIDER A MAJOR COMPLICATION, OCCURRED ONLY IN ONE PATIENT. NO OTHER MAJOR COMPLICATIONS WERE SEEN IN EITHER GROUP. SEVERE PAIN, ECCHYMOSIS, AND SENSITIVITY WERE THE MOST COMMON OF THE SIDE EFFECTS, AND THESE SIDE EFFECTS WERE SIGNIFICANTLY HIGHER IN RFA GROUP THAN IN CAE GROUP. PARESTHESIA WAS SEEN IN THREE PATIENTS, HEMATOMA IN ONE PATIENT, AND ANESTHESIA-RELATED URINARY RETENTION IN THREE PATIENTS WAS SEEN IN THE RFA GROUP, BUT NONE OCCURRED IN THE CAE GROUP. MAJOR COMPLICATIONS, SUCH AS DVT, WERE NOT OBSERVED IN EITHER GROUP IN OUR STUDY. PAIN, ECCHYMOSIS, AND SENSITIVITY WERE THE MOST COMMON SIDE EFFECTS AND THESE SIDE EFFECTS WERE SIGNIFICANTLY HIGHER IN THE RFA THAN IN THE CAE GROUP. THERE WAS ONLY ONE SLIGHT HEMATOMA THAT DEVELOPED IN ONE PATIENT IN OUR STUDY. SKIN BURN ON A SMALL AREA OCCURRED IN ONE PATIENT OWING TO A SUPERFICIAL GSV, AND SLIGHT PARESTHESIA DEVELOPED IN THREE PATIENTS BECAUSE OF RFA¿S HIGH THERMAL EFFECT. THESE COMPLICATIONS QUICKLY IMPROVED WITH SIMPLE MEDICAL INTERVENTIONS. A PIGMENTATION INCREASE WAS OBSERVED IN FOUR PATIENTS IN RFA GROUP AND TWO PATIENTS IN CAE GROUP AT SUPERFICIAL SMALL PARTS CLOSE TO THE ENTRY POINT. CONCLUSIONS: BASED ON THE PRESENT DATA, OUR FINDINGS SUGGEST THAT CAE IS AS EFFECTIVE AS RFA ABLATION WITH SIMILAR RATES OF SUCCESSFUL OCCLUSION. CAE MAY BE ASSOCIATED WITH LESS PAIN AND FEWER COMPLICATIONS THAN RFA AND MIGHT PROVIDE BETTER PATIENT COMFORT. THE CURRENT RESULTS SHOULD BE VERIFIED WITH FURTHER RANDOMIZED, CONTROLLED TRIALS WITH LONGER TERM FOLLOW-UP AND LARGER PATIENT GROUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233099 RADIOFREQUENCY GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention