BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19043620 · Received April 4, 2024

    Report

    Report Number
    2124215-2024-20278
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    April 19, 2023
    Report Date
    April 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT - ARTICLE PUBLISH DATE USED AS EVENT DATE IS UNKNOWN. LITERATURE CITATION: SAW, J., INOHARA, T., GILHOFER, T., UCHIDA, N., PEARCE, C., DEHGHANI, P., ... & OHARA, G. E. (2023). THE CANADIAN WATCHMAN REGISTRY FOR PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE. CJC OPEN, 5(7), 522-529. HTTPS://DOI.ORG/10.1016/J.CJCO.2023.03.016.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT SERIOUS INJURIES OCCURRED. METHODS: SEVEN CANADIAN CENTERS IMPLANTING THE WATCHMAN CLOSURE DEVICE PARTICIPATED IN THIS PROSPECTIVE MULTICENTER, OBSERVATIONAL REGISTRY. ALL PROCEDURES WERE DONE UNDER GENERAL ANESTHESIA WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY GUIDANCE. PATIENTS WERE PROSPECTIVELY FOLLOWED FOR 2 YEARS. THE LONG-TERM STROKE RATE WAS COMPARED WITH THE EXPECTED RATE BASED ON THE CHA2DS2-VASC SCORE. A TOTAL OF 272 PATIENTS WERE ENROLLED IN THE CANADIAN WATCHMAN REGISTRY BETWEEN (B)(6) 2013 AND (B)(6) 2019. ABOUT ONE THIRD OF PATIENTS HAD A HISTORY OF STROKE, TRANSIENT ISCHEMIC ATTACK, OR SYSTEMIC EMBOLISMS. ALMOST ALL PATIENTS WERE EVALUATED BY PRE-PROCEDURAL TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), AND COMPUTED TOMOGRAPHY ANGIOGRAPHY WAS PERFORMED FOR MORE THAN HALF OF THE PATIENTS PRIOR TO THE PROCEDURE. THE WATCHMAN CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED IN 269 PATIENTS. RESULTS: THE PROCEDURE COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED INCLUDED: ONE MYOCARDIAL INFARCTION, FIVE PERICARDIAL EFFUSIONS WITH CARDIAC TAMPONADE THAT REQUIRED DRAINING THE EFFUSION, TWO EVENTS OF MAJOR BLEEDING, SIX SMALL PERICARDIAL EFFUSIONS WITH NO INTERVENTION REQUIRED, NINE EVENTS OF MINOR BLEEDING, AND ONE PROCEDURAL DEATH. DURING THE FOLLOW UP OF THESE PATIENTS THE ADVERSE EVENTS THAT WERE REPORTED TO HAVE OCCURRED INCLUDED THE FOLLOWING: TEN CEREBRAL VASCULAR ACCIDENTS, FOUR TRANSIENT ISCHEMIC ATTACKS, TWO MYOCARDIAL INFARCTIONS, TWENTY-FOUR EVENTS OF MAJOR BLEEDING, TWENTY-EIGHT EVENTS OF MINOR BLEEDING, FIVE DEVICE RELATED THROMBUS EVENTS, AND THREE EVENTS WHERE THE DEVICE DID NOT HAVE A FULL SEAL AND THERE WAS A LEAK OVER 5MM. THERE WERE TEN CARDIOVASCULAR DEATHS THAT WERE REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86565 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O