BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

    MDR report key: 22955916 · Received September 3, 2025

    Report

    Report Number
    2124215-2025-61566
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 18, 2025
    Report Date
    May 20, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT: EVENT DATE ESTIMATED AS 08/18/2025 THE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS 2025 AUG 18. D1: BRAND NAME IS BLANK BECAUSE THE DEVICE IS KNOWN TO BE A WATCHMAN LAA CLOSURE DEVICE, BUT THE EXACT BRAND NAME IS UNKNOWN. CITATION: SAITO T, TSURUTA H, KAJINO A, IWATA J, SAKATA S, RYUZAKI T, SAGO M, TANAKA S, CHATANI R, HACHINOHE D, NAGANUMA T, OHNO Y, TANI T, OKAMATSU H, MIZUTANI K, WATANABE Y, IZUMO M, SAJI M, MIZUNO S, UENO H, KUBO S, SHIRAI S, NAKASHIMA M, ASAMI M, YAMAMOTO M, IEDA M, HAYASHIDA K; OCEAN-LAAC INVESTIGATORS. IMPACT OF PERIDEVICE LEAK ON CLINICAL OUTCOMES AFTER LEFT ATRIAL APPENDAGE CLOSURE: THE OCEAN-LAAC REGISTRY. J AM HEART ASSOC. 2025 AUG 19;14(16):E044422. DOI: 10.1161/JAHA.125.044422. EPUB 2025 AUG 18. PMID: 40820980.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE: IT WAS REPORTED SERIOUS INJURIES OCCURRED. THIS MULTICENTER JAPANESE REGISTRY STUDY (OCEAN-LAAC) EVALUATED THE IMPACT OF PERI-DEVICE LEAK (PDL) AT THE TIME OF LEFT ATRIAL APPENDAGE CLOSURE (LAAC) ON CLINICAL OUTCOMES IN PATIENTS WITH ATRIAL FIBRILLATION (AF). A TOTAL OF 1,397 PATIENTS WHO UNDERWENT LAAC BETWEEN 2019 AND 2022 WERE ANALYZED. THE PRIMARY OUTCOME WAS TRANSIENT ISCHEMIC ATTACK (TIA), ISCHEMIC STROKE, OR SYSTEMIC EMBOLISM (SE) WITHIN 2 YEARS OF LAAC. THE SECONDARY OUTCOME WAS 2-YEAR ALL-CAUSE MORTALITY. CLINICAL FOLLOW-UPS WERE GENERALLY SCHEDULED FOR HOSPITAL DISCHARGE AND AT TO 90 DAYS, 180 DAYS, AND 1 YEAR AFTER LAAC. WITHIN 2 YEARS AFTER LAAC, 3 PATIENTS HAD TIA, 5 HAD SE, AND 33 HAD ISCHEMIC STROKE. THE MEDIAN FOLLOW-UP PERIOD WAS 367 DAYS [INTERQUARTILE RANGE, 247-428] DAYS. THE INCIDENCE OF TIA, ISCHEMIC STROKE, OR SE WAS SIGNIFICANTLY HIGHER IN PATIENTS WITH ANY TYPE OF PDL (GRAYS TEST, P=0.0036). FURTHERMORE, COMPARED WITH NO PDL, NOT ONLY 3 MM<PDL </=5 MM (GRAYS TEST P=0.002) BUT ALSO PDL </=3 MM (GRAYS TEST P=0.04) WAS ASSOCIATED WITH A SIGNIFICANTLY HIGHER RISK OF TIA, ISCHEMIC STROKE, OR SE. SECONDARY OUTCOME: THERE WERE 92 PATIENTS WHO DIED OF ALL CAUSES WITHIN 2 YEARS. THERE WAS NO SIGNIFICANT DIFFERENCE IN ALL-CAUSE MORTALITY BETWEEN PATIENTS WITH AND WITHOUT PDL IN EITHER THE CRUDE OR MATCHED COHORT. IN OUR STUDY, AMONG THE 33 PATIENTS WITH ISCHEMIC STROKE, THE CAUSES OF ISCHEMIC STROKE WERE IDENTIFIED AS 13 CASES OF CARDIOEMBOLIC STROKE, 3 CASES OF ATHEROSCLEROTIC STROKE, 2 CASES OF LACUNAR INFARCTION, AND THE REMAINING CASES WERE OF UNKNOWN ORIGIN. HOWEVER, DIAGNOSING THE CAUSE OF ISCHEMIC STROKE IN PATIENTS WITH AF IS VERY CHALLENGING. THERE IS A POSSIBILITY THAT DUAL CAUSES EXIST AS A CAUSE OF ISCHEMIC STROKE IN PATIENTS WITH AF. THEREFORE, MORE DETAILED STUDIES CONSIDERING THESE FACTORS SHOULD BE CONDUCTED IN THE FUTURE. CONCLUSIONS: PDL AT THE TIME OF DEVICE IMPLANTATION WAS ASSOCIATED WITH A HIGHER RISK OF TIA, ISCHEMIC STROKE, OR SE AFTER LAAC, EVEN FOR PDL </=3 MM. THEREFORE, AS MINIMAL PDL AS POSSIBLE SHOULD BE THE TARGET IN EVERY CASE. CITATION: SAITO T, TSURUTA H, KAJINO A, IWATA J, SAKATA S, RYUZAKI T, SAGO M, TANAKA S, CHATANI R, HACHINOHE D, NAGANUMA T, OHNO Y, TANI T, OKAMATSU H, MIZUTANI K, WATANABE Y, IZUMO M, SAJI M, MIZUNO S, UENO H, KUBO S, SHIRAI S, NAKASHIMA M, ASAMI M, YAMAMOTO M, IEDA M, HAYASHIDA K; OCEAN-LAAC INVESTIGATORS. IMPACT OF PERIDEVICE LEAK ON CLINICAL OUTCOMES AFTER LEFT ATRIAL APPENDAGE CLOSURE: THE OCEAN-LAAC REGISTRY. J AM HEART ASSOC. 2025 AUG 19;14(16):E044422. DOI: 10.1161/JAHA.125.044422. EPUB 2025 AUG 18. PMID: 40820980.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297226 SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other