BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 12321313 · Received August 13, 2021

    Report

    Report Number
    2134265-2021-10383
    Event Type
    Injury
    Date Received
    August 13, 2021
    Date of Event
    July 1, 2021
    Report Date
    August 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT - ESTIMATED BASED ON AWARE DATE OF (B)(6) 2021 AS THE EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERFORATION, PERICARDIAL EFFUSION AND CARDIAC TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH NO RECAPTURES REQUIRED. THERE WAS NO EFFUSION PRIOR OR IMMEDIATELY AFTER THE PROCEDURE VIA TRANSESOPHAGEAL ECHO (TEE) AND INTRACARDIAC ECHO (ICE) VIEWS. NO EFFUSION WAS PRESENT VIA LIMITED TRANSTHORACIC ECHO (TTE) 2 HOURS POST PROCEDURE AND THE PATIENT WAS DISCHARGED. APPROXIMATELY 12 HOURS LATER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN. THE PATIENT UNDERWENT EMERGENT LEFT HEART CATH AN NO ACUTE CORONARY LESION WAS FOUND. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND WAS NEGATIVE FOR PULMONARY EMBOLISM BUT POSITIVE FOR PERICARDIAL EFFUSION. AN ECHO WAS PERFORMED WHICH THEN SHOWED PERICARDIAL TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND 400 CC WAS REMOVED WITH HEMODYNAMIC IMPROVEMENT. THE PATIENT WAS HOSPITALIZED FOR 3 DAYS THEN DISCHARGED AFTER TWO NEGATIVE ECHO WITH TRIVIAL PERICARDIAL EFFUSION POST DRAIN REMOVAL. THE PATIENT MADE A FULL RECOVERY. THE PHYSICIAN BELIEVES THAT PATIENT HAD A HYPERDYNAMIC HYPERMOBILE LAA AND THE FORCEFUL CONTRACTIONS OF THE LAA AFTER DEVICE DEPLOYMENT RESULTED IN MICRO-PERFORATIONS IN THE LAA WALL AND SUBSEQUENT PERICARDIAL EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215727 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention