BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 18355805 · Received December 19, 2023

    Report

    Report Number
    2124215-2023-70045
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    November 30, 2023
    Report Date
    December 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE HEAL LAA STUDY ON (B)(6) 2023 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS AND HYPOTENSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED ON THE DAY OF ENROLLMENT IN THE STUDY. PRIOR TO THE PROCEDURE, HEPARIN WAS ADMINISTERED. THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 31MM WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH COMPLETE LAA SEAL DEPLOYMENT DEVICE DIAMETER OF 31MM. ON THE SAME DAY, THE PATIENT WAS DISCHARGED. ON (B)(6) 2023, 44 DAYS POST-IMPLANT PROCEDURE, THE PATIENT WAS SEEN FOR ROUTINE FOLLOW UP. TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED A PEDUNCULATED, MOBILE THROMBUS ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX PRO CLOSURE DEVICE AND A TRIVIAL PERICARDIAL EFFUSION. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL. THE PATIENT WAS HOSPITALIZED. THE NEXT DAY, CLOPIDOGREL WAS DISCONTINUED AND THE PATIENT WAS STARTED ON APIXABAN AND THE PATIENT WAS DISCHARGED HOME. THE NEXT DAY THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM WITH COMPLAINTS OF DIZZINESS AND BORDERLINE HYPOTENSION. THE PATIENT WAS HOSPITALIZED. THE PATIENT'S BLOOD PRESSURE WAS 86/55. COMPUTED TOMOGRAPHY, LAB TESTS, AND X-RAY WERE PERFORMED WHICH SHOWED NO PERICARDIAL EFFUSION. THE PATIENT WAS DIAGNOSED WITH HYPOTENSION DUE TO HYPOVOLEMIA. THE PATIENT WAS ADMINISTERED 1500CC OF NORMAL SALINE AND BLOOD PRESSURE IMPROVED. THE PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT. THE PATIENT WAS ON FOUR (4) BLOOD PRESS MEDICATIONS WHICH WERE ADJUSTED OR DISCONTINUED TO TREAT THE EVENT. THE PHYSICIAN CONCLUDED THAT THE HYPOTENSION APPEARED TO BE RELATED TO LACK OF ORAL HYDRATION. THE NEXT DAY THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350193 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION WS6031 0032012834 00191506004613

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization