BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 24343214 · Received February 16, 2026

    Report

    Report Number
    2183870-2026-00071
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    January 30, 2015
    Report Date
    February 16, 2026
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RANDOMIZED TRIAL COMPARING CYANOACRYLATE EMBOLIZATION AND RADIOFREQUENCY ABLATION FOR INCOMPETENT GREAT SAPHENOUS VEINS (VECLOSE) COPYRIGHT 2015 BY THE SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC. HTTP://DX.DOI.ORG/10.1016/J.JVS.2014.11.071 A2 AVERAGE AGE A3 MAJORITY GENDER B3 DATE OF PUBLICATION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    BACKGROUND: WHEREAS THERMAL ABLATION OF INCOMPETENT SAPHENOUS VEINS IS HIGHLY EFFECTIVE, ALL HEAT-BASED ABLATION TECHNIQUES REQUIRE THE USE OF PERIVENOUS SUBFASCIAL TUMESCENT ANESTHESIA, INVOLVING MULTIPLE NEEDLE PUNCTURES ALONG THE COURSE OF THE TARGET VEIN. PRELIMINARY EVIDENCE SUGGESTS THAT CYANOACRYLATE EMBOLIZATION (CAE) MAY BE EFFECTIVE IN THE TREATMENT OF INCOMPETENT GREAT SAPHENOUS VEINS (GSVS). WE REPORT HEREIN EARLY RESULTS OF A RANDOMIZED TRIAL OF CAE VS RADIOFREQUENCY ABLATION (RFA) FOR THE TREATMENT OF SYMPTOMATIC INCOMPETENT GSVS. METHODS: TWO HUNDRED TWENTY-TWO SUBJECTS WITH SYMPTOMATIC GSV INCOMPETENCE WERE RANDOMLY ASSIGNED TO RECEIVE EITHER CAE (N [ 108) WITH THE VENASEAL SAPHEON CLOSURE SYSTEM (SAPHEON, INC, MORRISVILLE, NC) OR RFA (N [ 114) WITH THE CLOSUREFASTSYSTEM (COVIDIEN, MANSFIELD, MASS). AFTER DISCHARGE, SUBJECTS RETURNED TO THE CLINIC ON DAY 3 AND AGAIN AT MONTHS 1 AND 3. THE STUDY¿S PRIMARY END POINT WAS CLOSURE OF THE TARGET VEIN AT MONTH 3 AS ASSESSED BY DUPLEX ULTRASOUND AND ADJUDICATED BY AN INDEPENDENT VA SCULAR ULTRASOUND CORE LABORATORY. STATISTICAL TESTING FOCUSED ON SHOWING NONINFERIORITY WITH A 10% DELTA CONDITIONALLY FOLLOWED BY SUPERIORITY TESTING. NO ADJUNCTIVE PROCEDURES WERE ALLOWED UNTIL AFTER THE MONTH 3 VISIT, AND MISSING MONTH 3 DATA WERE IMPUTED BY VARIOUS METHODS. SECONDARY END POINTS INCLUDED PATIENT-REPORTED PAIN DURING VEIN TREATMENT AND EXTENT OF ECCHYMOSIS AT DAY 3. ADDITIONAL ASSESSMENTS INCLUDED GENERAL AND DISEASE-SPECIFIC QUALITY OF LIFE SURVEYS AND ADVERSE EVENT RATES. RESULTS: ALL SUBJECTS RECEIVED THE ASSIGNED INTERVENTION. BY USE OF THE PREDICTIVE METHOD FOR IMPUTING MISSING DATA, 3-MONTH CLOSURE RATES WERE 99% FOR CAE AND 96% FOR RFA. ALL PRIMARY END POINT ANALYSES, WHICH USED VARIOUS METHODS TO ACCOUNT FOR THE MISSING DATA RATE (14%), SHOWED EVIDENCE TO SUPPORT THE STUDY¿S NONINFERIORITY HYPOTHESIS (ALL P .01); SOME OF THESE ANALYSES SUPPORTED A TREND TOWARD SUPERIORITY (P [ .07 IN THE PREDICTIVE MODEL). PAIN EXPERIENCED DURING THE PROCEDURE WAS MILD AND SIMILAR BETWEEN TREATMENT GROUPS (2.2 AND 2.4 FOR CAE AND RFA, RESPECTIVELY, ON A 10-POINT SCALE; P [ .11). AT DAY 3, LESS ECCHYMOSIS IN THE TREATED REGION WAS PRESENT AFTER CAE C OMPARED WITH RFA (P .01). OTHER ADVERSE EVENTS OCCURRED AT A SIMILAR RATE BETWEEN GROUPS AND WERE GENERALLY MILD AND WELL TOLERATED. CONCLUSIONS: CAE WAS PROVEN TO BE NONINFERIOR TO RFA FOR THE TREATMENT OF INCOMPETENT GSVS AT MONTH 3 AFTER THE PROCEDURE. BOTH TREATMENT METHODS SHOWED GOOD SAFETY PROFILES. CAE DOES NOT REQUIRE TUMESCENT ANESTHESIA AND IS ASSOCIATED WITH LESS POST PROCEDURE ECCHYMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25331 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention