BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 18334540 · Received December 15, 2023

    Report

    Report Number
    3005075853-2023-09463
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    March 21, 2023
    Report Date
    December 15, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/15/2023. B3: PUBLICATION YEAR OF 2023. D4: BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: LONG-TERM OUTCOME OF THORACOSCOPIC ABLATION AND RADIOFREQUENCY CATHETER ABLATION FOR PERSISTENT ATRIAL FIBRILLATION AS A DE NOVO PROCEDURE AUTHOR(S): JUWON KIM, JU YOUN KIM, DONG SEOP JEONG, TAE-WAN CHUNG, SEUNG-JUNG PARK, KYOUNG-MIN PARK, JUNE SOO KIM, JOO MYUNG LEE AND YOUNG KEUN ON. CITATION: EUROPACE (2023) 00, 1¿11; HTTPS://DOI.ORG/10.1093/EUROPACE/EUAD096 . THIS STUDY SOUGHT TO COMPARE THE LONG-TERM EFFICACY AND SAFETY OF THORACOSCOPIC ABLATION VS. RADIOFREQUENCY CATHETER ABLATION AS A DE NOVO PROCEDURE IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION. BETWEEN FEBRUARY 2012 AND DECEMBER 2020, 575 PATIENTS WHO UNDERWENT EITHER THORACOSCOPIC RADIOFREQUENCY CATHETER ABLATION FOR PERSISTENT ATRIAL FIBRILLATION WERE INCLUDED IN THE STUDY. AMONG THE 575 PATIENTS, 281 PATIENTS UNDERWENT THORACOSCOPIC ABLATION, 228 UNDERWENT RADIOFREQUENCY CATHETER ABLATION, AND 66 UNDERWENT HYBRID ABLATION DURING THE INDEX HOSPITALIZATION. PROCEDURES FOR THORACOSCOPIC ABLATION INVOLVED EPICARDIAL PULMONARY VEIN ISOLATION, GANGLIONATED PLEXI ABLATION, DISSECTION OF LIGAMENT OF MARSHALL, AND LEFT APPENDAGE EXCISION. ALL ABLATION PROCEDURES WERE PERFORMED USING COMPETITOR¿S DEVICES (MANUFACTURER: ATRICURE) WHILE THE DISSECTION OF LIGAMENT OF MARSHALL WAS PERFORMED USING ANOTHER COMPETITOR DEVICE (MANUFACTURER: MEDTRONIC). ONCE ALL ABLATION PROCEDURES WERE COMPLETED AND THE CONDUCTION BLOCK WAS CONFIRMED, THE LEFT ATRIUM APPENDAGE WAS REMOVED USING AN ECHELON FLEX 60 ARTICULATING ENDOSCOPIC LINEAR STAPLER (ETHICON ENDO-SURGERY INC.) OR THE ATRICLIP PRO DEVICE (MANUFACTURER: ATRICURE). THE STAPLER WAS USED IN 57.9 PERCENT OF PATIENTS, AND THE CLIP WAS USED IN 42.1 PERCENT OF THEM. MEANWHILE, THE RADIOFREQUENCY CATHETER ABLATION PROCEDURE AND HYBRID ABLATION PROCEDURES WERE PERFORMED USING COMPETITOR¿S DEVICES (MANUFACTURER: BIOSENSE). REPORTED COMPLICATIONS INCLUDED STROKE (N=?), HEART FAILURE (N=?), BLEEDING (N=?), PERICARDITIS (N=?), AND PLEURITIS (N=?) AND CARDIAC RELATED DEATH (N=?). IN CONCLUSION, AS A FIRST PROCEDURE IN PERSISTENT ATRIAL FIBRILLATION, THORACOSCOPIC ABLATION AND RADIOFREQUENCY CATHETER ABLATION SHOWED COMPARABLE EFFICACY, CLINICAL, AND SAFETY OUTCOMES DURING LONG-TERM FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2301715 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown