BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 24799463 · Received April 7, 2026

    Report

    Report Number
    3005075853-2026-02584
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    January 9, 2026
    Report Date
    April 14, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT: 4/7/2026. D4: BATCH # UNK. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY 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 DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/14/2026. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. NO FURTHER INFORMATION WILL BE PROVIDED BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE AUTHOR.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: NAKAYAMA T, ITO H, SATO S, KURE S, HAMA G, AOKI M, TAKAHASHI S. OUTCOMES OF THORACOSCOPIC LEFT ATRIAL APPENDAGE OCCLUSION WITH OR WITHOUT CONCOMITANT THORACOSCOPIC ABLATION - MULTICENTER RETROSPECTIVE REGISTRY OF 567 PATIENTS IN JAPAN. CIRC REP. 2026 JAN 9;8(3):391-399. DOI: 10.1253/CIRCREP.CR-25-0276. PMID: 41808952; PMCID: PMC12971204. THE AIM OF THIS STUDY WAS TO EVALUATE THE SAFETY, EFFICACY, AND CLINICAL OUTCOMES OF THORACOSCOPIC LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) USING STAPLER EXCISION OR EPICARDIAL CLIP. BOTH AS A STANDALONE PROCEDURE AND COMBINED WITH THORACOSCOPIC ABLATION, FOR STROKE PREVENTION IN JAPANESE PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION. BETWEEN MARCH 2018 AND DECEMBER 2024, 567 PATIENTS UNDERWENT THORACOSCOPIC LAAO. MEDIAN AGE WAS 72 YEARS [65¿78], AND 25% WERE WOMEN. IN THE CUT-AND-STAPLE METHOD: A LINEAR STAPLER (ECHELON FLEX, ETHICON, USA) WAS APPLIED FLUSH TO THE BASE OF THE LAA. IN CASES OF RESIDUAL POUCH, REINFORCEMENT WITH A LOOP TECHNIQUE WAS PERFORMED TO ENSURE COMPLETE EXCLUSION. REPORTED COMPLICATIONS INCLUDE: ECHELON FLEX (ETHICON). SEVERE ADHESIONS (N=1). TREATMENT: PROCEDURE WAS ABORTED. INTRAOPERATIVE BLOOD LOSS (N=6). TREATMENT: BLOOD TRANSFUSION, CONVERSION TO THORACOTOMY/STERNOTOMY. SURGICAL SITE INFECTION (N=2). TREATMENT: NOT REPORTED. IN CONCLUSION, THORACOSCOPIC LAAO, WITH OR WITHOUT ABLATION, IS SAFE AND EFFECTIVE FOR STROKE PREVENTION IN AF, WITH HIGH SUCCESS, RELIABLE CLOSURE, AND VERY LOW MIDTERM EVENTS. PERIOPERATIVE EVENTS STROKE, PHRENIC NERVE PALSY, DE NOVO PACEMAKER IMPLANTATION HAS NO CORRELATION TO THE USE OF ECHELON FLEX IN THIS STUDY. THUS, EXCLUDED. THE 13 DEATHS THAT WERE MENTIONED IN THIS STUDY HAD NO CORRELATION TO THE USE OF ECHELON FLEX IN THIS STUDY. THUS, EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71509 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention