BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 23449997 · Received November 3, 2025

    Report

    Report Number
    2183870-2025-00506
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    December 9, 2016
    Report Date
    November 3, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE TITLE OUT COMES OF A SINGLE-CENTER EXPERIENCE WITH CLASSIFICATION AND TREATMENT OF ENDOTHERMAL HEAT INDUCED THROMBOSIS AFTE R ENDOVENOUS ABLATION COPYRIGHT 2017 BY THE SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC. HTTP://DX.DOI.ORG/10.1016/J.JVSV.2016.12.010 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

    OBJECTIVE: ENDOTHERMAL HEAT-INDUCED THROMBOSIS (EHIT) IS A KNOWN COMPLICATION OF ENDOTHERMAL VENOUS ABLATION PROCEDURES. EHIT CAN LEAD TO DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM, WHICH CAUSE SIGNIFICANT DISABILITY AND, RARELY, DEATH. OTHER STUDIES HAVE EVALUATED RISK FACTORS FOR EHIT. THERE IS AN ACCEPTED GRADING SYSTEM FOR EHIT, BUT THERE IS NO CONSENSUS ON TREATMENT TYPE, DURATION, OR FOLLOW-UP. WE RETROSPECTIVELY EVALUATED ALL CASES OF EHIT AFTER RADIOFREQUENCY ABLATION OR ENDOVENOUS LASER ABLATION AT OUR INSTITUTION DURING A 7-YEAR PERIOD, FOCUSING ON CLASSIFICATION, TREATMENT, AND OUTCOMES OF EHIT. METHODS: THE ANALYSIS INCLUDED ALL PATIENTS AGED >18 YEARS WHO UNDERWENT RADIOFREQUENCY ABLATION OR ENDOVENOUS LASER ABLATION AT OUR INSTITUTION, SPECTRUM HEALTH HOSPITAL VEIN SOLUTIONS (GRAND RAPIDS, MICH), BETWEEN JANUARY 1, 2008, AND DECEMBER 31, 2014. ELECTRONIC MEDICAL RECORDS WERE QUERIED RETROSPECTIVELY TO IDENTIFY PATIENTS WITH EHIT DURING THE STUDY INTERVAL BY INTERNATIONAL CLASSIFICATION OF DISEASES-NINTH REVISION CODE. DEMOGRAPHIC DATA, INCLUDING AGE, GENDER, COMORBIDITIES (EG, HISTORY OF DEEP VENOUS THROMBOSIS, HYPERCOAGULABLE STATE, FAMILY HISTORY OF BLOOD CLOTS, ETC), BODY MASS INDEX, CLINICAL, ETIOLOGY, ANATOMY, AND PATHOPHYSIOLOGY (CEAP) CLASSIFICATION, AND USE OF PREOPERATIVE ANTIC OAGULATION WERE COLLECTED FOR EACH PATIENT IN THE REGISTRY. EACH PATIENT HAD A REQUIRED POSTOPERATIVE DUPLEX ULTRASOUND (US) EXAMINATION WITHIN 1 TO 2 WEEKS OF THE PROCEDURE. PREOPERATIVE AND POSTOPERATIVE US IMAGING DATA AND PROCEDURE-SPECIFIC DATA WERE ALSO RECO RDED FOR EACH PATIENT. EHIT WAS GRADED FROM 1 TO 4 BY REVIEW OF THE US STUDIES. EACH PATIENT¿S TREATMENT COURSE WAS REVIEWED FOR TYPE OF ANTICOAGULATION, DURATION OF TREATMENT, FOLLOW-UP IMAGING, AND OUTCOME. RESULTS: FROM 2008 TO 2014, 4799 ABLATIONS WERE PERFORMED AT SPECTRUM HEALTH HOSPITAL VEIN CENTER, AND EHIT WAS IDENTIFIED IN 70 PATIENTS. AT PRESENTATION, 87% OF PATIENTS WERE ASYMPTOMATIC, 10% REPORTED PAIN, AND 2.9% REPORTED SWELLING. PATIENTS WITH EHIT GRADES 1 OR 2 WERE TREATED WITH DAILY ASPIRIN, AND MOST OF THOSE WITH GRADES 3 OR 4 WERE TREATED WITH SYSTEMIC ANTICOAGULATION. REPEAT US IMAGING WAS PERFORMED AT 1 TO 2 WEEKS TO EVALUATE PROGRESSION. PROGRESSION WAS NOT SEEN IN ANY PATIENTS TREATED WITH SYSTEMIC ANTICOAGULATION (GRADES 3-4). THROMBUS PROGRESSION OCCURRED IN TWO PATIENTS WITH GRADES 1 OR 2 EHIT TREATED WITH ASPIRIN. A BLEEDING COMPLICATION OCCURRED IN ONE PATIENT. CONCLUSIONS: EHIT AFTERENDOVENOUS ABLATION OCCURRED IN W1.5% OF PATIENTS, WHICH IS SIMILAR TO THAT REPORTED IN THE LITERATURE. OUR REVIEW SHOWS THAT SYSTEMIC ANTICOAGULATION IS EFFECTIVE IN THE PREVENTION OF PROGRESSION WITH A LOW RISK OF BLEEDING COMPLICATIONS. PATIENTS WITH EHIT GRADES 1 OR 2 CAN BE TREATED WITH ASPIRIN ALONE WITH A LOW RISK OF PROGRESSION (3%). (J VASC SURG: VENOUS AND LYM DIS 2017;5:332-8.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886893 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention