BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 15992703 · Received December 15, 2022

    Report

    Report Number
    2183870-2022-00420
    Event Type
    Injury
    Date Received
    December 15, 2022
    Date of Event
    February 23, 2022
    Report Date
    December 15, 2022
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: JOURNAL: JOURNAL OF VASCULAR SURGERY VENOUS & LYMPHATIC DISORDERS ISSUE#: VOL 10, ISSUE 5, P993-998 TITLE OF ARTICLE: A SINGLE-CENTER EXPERIENCE OF ANTERIOR ACCESSORY SAPHENOUS VEIN ENDOTHERMAL ABLATION DEMONSTRATES SAFETY AND EFFICACY LITERATURE REFERENCE: DOI.ORG/10.1016/J.JVSV.2022.02.009. AVERGAE AGE. MAJORITY SEX. MAJORITY ETHNICITY. MAJORITY RACE MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 · 0

    MEDTRONIC RECEIVED A JOURNAL ARTICLE REPORTING ON ' A SINGLE-CENTER EXPERIENCE OF ANTERIOR ACCESSORY SAPHENOUS VEIN ENDOTHERMAL ABLATION DEMONSTRATES SAFETY AND EFFICACY'. THIS RETROSPECTIVE REVIEW INCLUDED 314 LIMBS AT A SINGLE ACADEMIC INSTITUTION FROM 2016 TO 2018 USING THE INSTITUTIONAL VASCULAR QUALITY INITIATIVE DATABASE. ALL LIMBS HAD DOCUMENTED AASV REFLUX. BASELINE CHARACTERISTICS WERE EVALUATED INCLUDING AGE; SEX; ETHNICITY; CLINICAL, ETIOLOGY, ANATOMY, PATHOPHYSIOLOGY CLASSIFICATION; VENOUS CLINICAL SEVERITYSCORE (VCSS); AND VEIN DIAMETER. POSTPROCEDURAL VARIABLES INCLUDED TREATMENT MODALITY AND LENGTH, AND POSTPROCEDURAL OUTCOMES INCLUDED SUCCESSFUL ABLATION ON POSTPROCEDURAL IMAGING, POSTPROCEDURAL VCSS LATEST FOLLOW-UP, ENDOTHERMAL HEAT-INDUCED THROMBOSIS (EHIT), AND ANY POSTPROCEDURAL COMPLICATION. POSTPROCEDURAL FOLLOW-UP IMAGING AND ABLATION CONFIRMATION CONSISTED OF VENOUS DUPLEX ULTRASOUND (DUS) EXAMINATION. POSTPROCEDURE VENOUS DUS EXAMINATION WAS PERFORMED 3 TO 7 DAYS AFTER THE PROCEDURE TO SPECIFICALLY ASSESS FOR EHIT. SURVEILLANCE WAS ALSO PERFORMED AT 3 TO 6 MONTHS, AND THEN ANNUALLY THEREAFTER IF DEEMED INDICATED AND AT THE DISCRETION OF THE OPERATOR. TREATMENT WAS PERFORMED USING THE MEDTRONIC CLOSUREFAST ENDOVENOUS RFA SYSTEM, NON-MEDTRONIC EVLA (1470 NM) OR OR MICROPHLEBECTOMY. ISOLATED MICROPHLEBECTOMY OF THE AASV WAS ONLY PERFORMED FOR AN INABILITY TO CANNULATE THE VEIN. HIGH LIGATION WAS NOT PERFORMED IN THIS COHORT. THE RFA OR EVLA CATHETER TIP WAS PLACED 2.5 CM OR MORE FROM THE SAPHENOFEMORAL JUNCTION IN ALL PATIENTS. A TOTAL OF 314 LIMBS WITH ANTERIOR ACCESSORY SAPHENOUS VEIN (AASV) REFLUX UNDERWENT ENDOTHERMAL ABLATION OR MICROPHLEBECTOMY. TREATMENT MODALITIES INCLUDED RFA IN 59.2% (N ¼ 186), EVLA IN 37.9% (N ¼ 119), AND MICROPHLEBECTOMY IN 2.9% (N ¼ 9). OF THE TREATED LIMBS, 38.5% (N ¼ 121) UNDERWENT CONCOMITANT MICROPHLEBECTOMY AT THE TIME OF ENDOVENOUS ABLATION FOR VV IN THE AASV DISTRIBUTION. THERE WAS A 96.5% TECHNICAL SUCCESS RATE WITH ENDOTHERMAL ABLATION, 0.6% INCIDENCE OF ENDOTHERMAL HEAT INDUCED THROMBOSIS, AND NO OTHER COMPLICATIONS. ISOLATED MICROPHLEBECTOMY WAS PERFORMED IN NINE PATIENTS WHOSE VEINS COULD NOT BE CANNULATED. DUS EXAMINATION WAS PERFORMED IN 312 LIMBS, REVEALING SUCCESSFUL ABLATION IN 96.5% (N ¼ 303). OF THE NINE LIMBS (3.5%) WHOSE INITIAL PROCEDURE FAILED, FIVE (56.0%) WERE TREATED USING RFA AND FOUR (44.0%) WERE TREATED USING EVLA, EQUATING TO A 2.7% AND A 3.4% FAILURE RATE FOR RFA AND EVLA, RESPECTIVELY. THE AVERAGE DURATION OF FOLLOW-UP WITH VENOUS DUS EXAMINATION WAS 2.2 +/- 2.3 YEARS, WITH TWO LIMBS LOST TO FOLLOW-UP. VCSS SCORES AFTER THE PROCEDURE WERE AVAILABLE FOR 145 LIMBS AND AVERAGED 4.45 +/- 2.31 AT AN AVERAGE FOLLOW-UP OF 1.96 +/- 2.25 YEARS. THIS FINDING REPRESENTS A SIGNIFICANT DECREASE FROM THE PREPROCEDURE VCSS SCORES (P .01). REGARDING COMPLICA TIONS THE TWO 2 LIMBS (0.6%) THAT EXHIBITED POSTPROCEDURAL EHIT II WERE BOTH WERE TREATED WITH THERAPEUTIC ENOXAPARIN FOR 1 WEEK. REPEAT DUS EXAMINATION REVEALED THROMBUS RESOLUTION IN ONE LIMB; THE OTHER PATIENT WAS LOST TO FOLLOW-UP. THERE WERE NO OTHER POSTPROCEDURAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570563 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention