BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

    MDR report key: 24445509 · Received February 25, 2026

    Report

    Report Number
    2124215-2026-10508
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    February 12, 2026
    Report Date
    April 27, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: PALMEZANO-DIAZ, ET AL. (2025). CIERRE DE OREJUELA EN PACIENTES CON FIBRILACION AURICULAR EN TERAPIA DE REEMPLAZO RENAL. REVISTA COLOMBIANA DE CARDIOLOGIA, 32(1), 19-24. EPUB MARCH 05, 2025.HTTPS://DOI.ORG/10.24875/RCCAR.23000067. B3: BOSTON SCIENTIFIC AWARE DATE USED AS EVENT DATE AS IT IS UNKNOWN. D1: BRAND NAME IS BLANK BECAUSE THE DEVICE IS KNOWN TO BE A WATCHMAN LAA CLOSURE DEVICE AND WATCHMAN ACCESS SYSTEM, BUT THE EXACT BRAND NAME IS UNKNOWN. D4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT SERIOUS INJURIES OCCURRED. THE FOLLOWING EVENT WAS OBTAINED FROM A RETROSPECTIVE, MULTICENTER STUDY EVALUATING LEFT ATRIAL APPENDAGE CLOSURE (LAAC) IN 25 PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION UNDERGOING RENAL REPLACEMENT THERAPY BETWEEN 2017 AND 2022. 76% OF PATIENTS RECEIVED A WATCHMAN CLOSURE DEVICE AND 24% RECEIVED A NON-BOSTON SCIENTIFIC LAAC DEVICE. ACUTE PROCEDURAL COMPLICATIONS OCCURRED IN FOUR PATIENTS (16%). THESE INCLUDED ONE ACCESS SITE HEMATOMA NOT REQUIRING INTERVENTION, ONE ARTERIOVENOUS FISTULA REQUIRING SURGICAL REPAIR, ONE CARDIAC TAMPONADE REQUIRING PERICARDIAL DRAINAGE, AND ONE INTRACAVITARY THROMBUS RESULTING IN INABILITY TO COMPLETE LAAC. ONE PATIENT EXPERIENCED A MILD HEMORRHAGIC CEREBROVASCULAR EVENT DURING FOLLOW-UP THAT DID NOT REQUIRE SURGICAL INTERVENTION AND WAS REPORTED AS POSSIBLY RELATED TO RESIDUAL ANTIPLATELET THERAPY. ALTHOUGH THERE WERE CASES OF MORTALITY IN THE FOLLOW UP PERIOD, THE CAUSES OF DEATH INCLUDED COMPLICATIONS SPECIFICALLY RELATED TO RENAL DISEASE (20%), DIABETES-RELATED COMPLICATIONS (4%), AND ADVANCED ONCOLOGIC DISEASE (4%); NO DEATHS WERE ATTRIBUTED TO THE WATCHMAN CLOSURE DEVICE OR THE LAAC PROCEDURE. THEREFORE THERE WERE NO INTERVENTION OR PROCEDURE RELATED ISCHEMIC CARDIOVASCULAR EVENTS OR DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165629 SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention