BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 18955190 · Received March 21, 2024

    Report

    Report Number
    2124215-2024-16564
    Event Type
    Death
    Date Received
    March 21, 2024
    Date of Event
    August 14, 2023
    Report Date
    March 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: LAKKIREDDY, D., THALER, D., ELLIS, C. R., SWARUP, V., GAMBHIR, A., HERMILLER, J.,& WINDECKER, S. (2023). 3-YEAR OUTCOMES FROM THE AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER RANDOMIZED CONTROLLED TRIAL (AMULET IDE). JACC: CARDIOVASCULAR INTERVENTIONS, 16(15), 1902-1913. HTTPS://DOI.ORG/10.1016/J.JCIN.2023.06.022. B3: EVENT DATE - ESTIMATED AS THE DATE THE ARTICLE WAS PUBLISHED.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED VIA JOURNAL ARTICLE THAT PATIENT DEATHS OCCURRED. THE AMULET IDE TRIAL USED 1:1 RANDOMIZATION TO COMPARE THE SAFETY AND EFFECTIVENESS OF THE AMULET OCCLUDER TO THE WATCHMAN DEVICE. ELIGIBLE PATIENTS WERE 18 YEARS OF AGE OR OLDER WITH DOCUMENTED PAROXYSMAL, PERSISTENT, OR PERMANENT NVAF AND DEEMED TO BE AT HIGH RISK OF STROKE OR SYSTEMIC EMBOLISM (SE). A TOTAL OF 1,878 PATIENTS WERE RANDOMIZED FROM (B)(6) 2016 THROUGH (B)(6) 2019, AND 1,833 UNDERWENT A DEVICE IMPLANT ATTEMPT (917 AMULET OCCLUDER GROUP PATIENTS AND 916 WATCHMAN DEVICE GROUP PATIENTS). RESULTS: THE 3-YEAR FOLLOW-UP VISIT WAS COMPLETED IN 1,380 PATIENTS (721 AMULET OCCLUDER GROUP AND 659 WATCHMAN DEVICE GROUP). PATIENTS THAT RECEIVED THE WATCHMAN CLOSURE DEVICE WERE REPORTED TO HAVE EXPERIENCED SERIOUS INJURIES. 36 PATIENTS EXPERIENCED AN ISCHEMIC STROKE, 2 PATIENTS EXPERIENCED A SYSTEMIC EMBOLISM, 42 PATIENTS WERE REPORTED TO HAVE EXPERIENCED A CEREBRAL VASCULAR ACCIDENT, 14 PATIENTS EXPERIENCED A PERICARDIAL EFFUSION, 7 PATIENTS HAD A HEMATOMA, 1 PATIENT HAD A PLEURAL EFFUSION, 3 PATIENTS EXPERIENCED DEVICE RELATED THROMBUS, AND 17 PATIENTS HAD A DEVICE THAT DID NOT SEAL. IT WAS REPORTED THAT A TOTAL OF 70 PATIENT DEATH OCCURRED. 5 PATIENTS EXPERIENCED DEVICE RELATED THROMBUS, 17 PATIENTS HAD A DEVICE THAT DID NOT SEAL, 1 PATIENT HAD A PERICARDIAL EFFUSION THAT LED TO A PROCEDURAL PATIENT DEATH, AND THE REMAINING PATIENTS WERE NOT NOTED WITH OTHER PATIENT INJURIES OTHER THAN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2276054 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death