BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 20955836 · Received December 17, 2024

    Report

    Report Number
    2124215-2024-79488
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    May 30, 2024
    Report Date
    December 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED AS 05/30/2024 AS THE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS 2024 MAY 30. LITERATURE CITATION: ABRAMOVITZ FOUKS A, YAGHI S, GOKCAL E, DAS AS, ROTSCHILD O, SILVERMAN SB, SINGHAL AB, ROMERO J, KAPUR S, GREENBERG SM, GUROL ME. LEFT ATRIAL APPENDAGE CLOSURE FOR PATIENTS WITH ATRIAL FIBRILLATION AT HIGH INTRACRANIAL HAEMORRHAGIC RISK. STROKE VASC NEUROL. 2024 MAY 30:SVN-2024-003142. DOI: 10.1136/SVN-2024-003142. EPUB AHEAD OF PRINT. PMID: 38821554.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE IT WAS REPORTED VIA JOURNAL ARTICLE THAT SERIOUS INJURIES OCCURRED. THE FOLLOWING EVENT WAS OBTAINED VIA A RETROSPECTIVE ARTICLE FOLLOWING 146 PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION (NVAF) THAT UNDERWENT A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE BETWEEN 2016 AND 2022 BECAUSE OF PRIOR INTRACRANIAL HEMORRHAGE (ICH) OR THE PRESENCE OF HIGH ICH RISK IMAGING MARKERS ON BRAIN MAGNETIC RESONANCE IMAGING (MRI) (CEREBRAL MICROBLEEDS (CMBS)). AMONG 146 PATIENTS WITH NVAF WHO UNDERWENT LAAC FOR HIGH ICH RISK, 122 HAD A HISTORY OF ICH, WHILE 24 PRESENTED WITH HIGH ICH RISK IMAGING MARKERS ONLY. MEAN AGE WAS 75.7-7.61, 42 (28.8%) WERE WOMEN. MEAN CHA2DS2-VASC SCORE WAS 5.23 -1.52. OF 122 PATIENTS WITH ICH HISTORY, 58 (47.5%) HAD INTRAPARENCHYMAL HEMORRHAGE (IPH), 40 (32.8%) HAD TRAUMATIC ICH (T-ICH) AND 18 (14.7%) HAD NON-TRAUMATIC SUBDURAL HEMORRHAGE. OF 85 PATIENTS WITH BRAIN MRIS INCLUDING NECESSARY SEQUENCES, 43 (50.6%) WERE RELATED TO CEREBRAL AMYLOID ANGIOPATHY AND 37 (43.5%) TO HYPERTENSIVE MICROANGIOPATHY. WHILE 70% OF PATIENTS WERE DISCHARGED ON ORAL ANTICOAGULANTS (OAC), 92% WERE NOT TAKING OAC AT 1 YEAR. DURING THE PROCEDURE, TWO PATIENTS SUFFERED PERICARDIAL EFFUSION. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PERFORMED 6 WEEKS POST PROCEDURE REVEALED DEVICE-RELATED THROMBUS IN TWO PATIENTS WHILE THEY WERE STILL ON OAC TREATMENT. ON FOLLOW-UP TEES, THROMBI RESOLVED, AND PATIENTS WERE SWITCHED TO ANTIPLATELET-ONLY THERAPY. FORTY PATIENTS (27.4%) HAD PERI-DEVICE LEAK ON TEE 6 WEEKS POST PROCEDURE, BUT NONE OF THEM HAD A PERI-DEVICE LEAK GREATER THAN 5 MM OR NEEDED FURTHER INTERVENTION FOR THIS MATTER. TWO PATIENTS HAD MYOCARDIAL INFARCTION DURING FOLLOW-UP PERIOD AND THREE PATIENTS HAD A MAJOR NON-CEREBRAL BLEEDING WHILE USING ANTIPLATELET THERAPY ONLY. OVER 2.12 YEARS MEAN FOLLOW-UP, 1 PATIENT HAD RECURRENT NON-TRAUMATIC ICH, 5 HAD T-ICH AND 6 HAD AN ISCHEMIC STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485364 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other