BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 11554834 · Received March 23, 2021

    Report

    Report Number
    2134265-2021-03615
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    October 30, 2020
    Report Date
    March 23, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT A TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. PRIOR TO THE INDEX PROCEDURE APIXABAN WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 23.5 MM. AFTER THE IMPLANT THE SUBJECT WAS STARTED ON BOTH ASPIRIN AND APIXABAN. ON (B)(6) 2020, THE SUBJECT WAS DISCHARGED. A 3-MONTH FOLLOW-UP TEE WAS PERFORMED ON (B)(6) 2020 AND THE RESULTS DID NOT REVEAL ANY EVIDENCE OF THROMBUS. ON (B)(6) 2020, THE SUBJECT WAS ADMITTED TO THE HOSPITAL FOR REPEAT ABLATION OF ATYPICAL ATRIAL FLUTTER. THE SUBJECT UNDERWENT SUCCESSFUL ABLATION OF ATYPICAL FLUTTER AND PULMONARY VEIN ISOLATION ABLATION FOR ATRIAL FIBRILLATION (AF). DUE TO SUBJECT'S HIGH RISK OF FALLS, HISTORY OF CHRONIC ANTICOAGULATION, STROKE DUE TO EMBOLISM OF RIGHT POSTERIOR CEREBRAL ARTERY, THE SUBJECT WAS RECOMMENDED FOR AN MAGNETIC RESONANCE IMAGING (MRI) AND COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD AND NECK. ON (B)(6) 2020, 106 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH TIA FOLLOWING THE REPEAT AF ABLATION. AT THE TIME OF EVENT, THE SUBJECT WAS ON ASPIRIN AND APIXABAN. NO CORRECTIVE ACTION WAS PERFORMED TO TREAT THE EVENT AND ON (B)(6) 2020, THE EVENT WAS CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451932 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10393 0024354602

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other