BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 11842582 · Received May 18, 2021

    Report

    Report Number
    2134265-2021-06456
    Event Type
    Injury
    Date Received
    May 18, 2021
    Date of Event
    April 26, 2021
    Report Date
    October 20, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5: UPDATED.

    Additional Manufacturer Narrative · 0

    B5: UPDATED. B7: UPDATED.

    Description of Event or Problem · 0

    FLXIBILITY STUDY IT WAS REPORTED THROMBUS OCCURRED. ON (B)(6) 2020 A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 27 MM WATCHMAN FLX DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 24.0 MM. PRIOR TO THE PROCEDURE 300 MG CLOPIDOGREL WAS ADMINISTERED. LAA IMAGING POST IMPLANT REVEALED COMPLETE LAA SEAL WITH NO EVIDENCE OF THROMBUS ON THE ATRIAL SURFACE OF THE DEVICE AND LEFT ATRIUM, 2 MM OF PERICARDIAL EFFUSION (NOT CAUSED/WORSENED BY IMPLANT PROCEDURE) AND ATRIAL SEPTAL SHUNT OF LESS THAN OR EQUAL TO 3 MM SIZE WERE NOTED. THE PATIENT WAS DISCHARGED WITH ASPIRIN AND CLOPIDOGREL. ASPIRIN AND CLOPIDOGREL WAS STOPPED ON (B)(6), 2020 AS THE PATIENT WAS NOT ABLE TO TOLERATE THE MEDICATION. THE FOLLOW UP TRANSTHORACIC ECHOCARDIOGRAM (TTE) DATED (B)(6), 2020 REVEALED COMPLETE LAA SEAL WITH NO EVIDENCE OF THROMBUS ON THE ATRIAL SURFACE OF THE DEVICE AND LEFT ATRIUM, NO EVIDENCE OF PERICARDIAL EFFUSION AND ATRIAL SEPTAL SHUNT WERE NOTED. ON (B)(6) 2021, 418 DAYS POST PROCEDURE, THE PATIENT PRESENTED FOR A FOLLOW UP VISIT AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED COMPLETE LAA SEAL WITH PRESENCE OF PEDUNCULATED MOBILE THROMBUS ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE WITH MAXIMUM AREA OF 0.8 CM SQUARED WAS NOTED. HOWEVER, NO EVIDENCE OF THROMBUS IN THE LEFT ATRIUM, PERICARDIAL EFFUSION AND ATRIAL SEPTAL SHUNT WERE NOTED. THE PATIENT WAS NOT ON ANY ANTIPLATELET ANTICOAGULANT THERAPY. IT WAS FURTHER REPORTED THAT ENOKSAPARIN WAS STARTED IN RESPONSE TO THE EVENT.

    Description of Event or Problem · 0

    FLXIBILITY STUDY. IT WAS REPORTED THROMBUS OCCURRED. ON (B)(6) 2020 A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 27 MM WATCHMAN FLX DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 24.0 MM. PRIOR TO THE PROCEDURE 300 MG CLOPIDOGREL WAS ADMINISTERED. LAA IMAGING POST IMPLANT REVEALED COMPLETE LAA SEAL WITH NO EVIDENCE OF THROMBUS ON THE ATRIAL SURFACE OF THE DEVICE AND LEFT ATRIUM, 2 MM OF PERICARDIAL EFFUSION (NOT CAUSED/WORSENED BY IMPLANT PROCEDURE) AND ATRIAL SEPTAL SHUNT OF LESS THAN OR EQUAL TO 3 MM SIZE WERE NOTED. THE PATIENT WAS DISCHARGED WITH ASPIRIN AND CLOPIDOGREL. ASPIRIN AND CLOPIDOGREL WAS STOPPED ON (B)(6) 2020 AS THE PATIENT WAS NOT ABLE TO TOLERATE THE MEDICATION. THE FOLLOW UP TRANSTHORACIC ECHOCARDIOGRAM (TTE) DATED (B)(6) 2020 REVEALED COMPLETE LAA SEAL WITH NO EVIDENCE OF THROMBUS ON THE ATRIAL SURFACE OF THE DEVICE AND LEFT ATRIUM, NO EVIDENCE OF PERICARDIAL EFFUSION AND ATRIAL SEPTAL SHUNT WERE NOTED. ON (B)(6), 2021, 418 DAYS POST PROCEDURE, THE PATIENT PRESENTED FOR A FOLLOW UP VISIT AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED COMPLETE LAA SEAL WITH PRESENCE OF PEDUNCULATED MOBILE THROMBUS ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE WITH MAXIMUM AREA OF 0.8 CM SQUARED WAS NOTED. HOWEVER, NO EVIDENCE OF THROMBUS IN THE LEFT ATRIUM, PERICARDIAL EFFUSION AND ATRIAL SEPTAL SHUNT WERE NOTED. THE PATIENT WAS NOT ON ANY ANTIPLATELET ANTICOAGULANT THERAPY. IT WAS FURTHER REPORTED THAT ENOKSAPARIN WAS STARTED IN RESPONSE TO THE EVENT. IT WAS FURTHER REPORTED THAT AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS CONSIDERED TO BE UNKNOWN. FURTHER FOLLOW-UP TEE WAS SCHEDULED AFTER 2 MONTHS.

    Description of Event or Problem · 1

    FLEXIBILITY STUDY. IT WAS REPORTED THROMBUS OCCURRED. ON (B)(6) 2020 A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 27 MM WATCHMAN FLX DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 24.0 MM. PRIOR TO THE PROCEDURE 300 MG CLOPIDOGREL WAS ADMINISTERED. LAA IMAGING POST IMPLANT REVEALED COMPLETE LAA SEAL WITH NO EVIDENCE OF THROMBUS ON THE ATRIAL SURFACE OF THE DEVICE AND LEFT ATRIUM, 2 MM OF PERICARDIAL EFFUSION (NOT CAUSED/WORSENED BY IMPLANT PROCEDURE) AND ATRIAL SEPTAL SHUNT OF LESS THAN OR EQUAL TO 3 MM SIZE WERE NOTED. THE PATIENT WAS DISCHARGED WITH ASPIRIN AND CLOPIDOGREL. ASPIRIN AND CLOPIDOGREL WAS STOPPED ON (B)(6) 2020 AS THE PATIENT WAS NOT ABLE TO TOLERATE THE MEDICATION. THE FOLLOW UP TRANSTHORACIC ECHOCARDIOGRAM (TTE) DATED JUNE 2, 2020 REVEALED COMPLETE LAA SEAL WITH NO EVIDENCE OF THROMBUS ON THE ATRIAL SURFACE OF THE DEVICE AND LEFT ATRIUM, NO EVIDENCE OF PERICARDIAL EFFUSION AND ATRIAL SEPTAL SHUNT WERE NOTED. ON (B)(6) 2021, 418 DAYS POST PROCEDURE, THE PATIENT PRESENTED FOR A FOLLOW UP VISIT AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED COMPLETE LAA SEAL WITH PRESENCE OF PEDUNCULATED MOBILE THROMBUS ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE WITH MAXIMUM AREA OF 0.8 CM SQUARED WAS NOTED. HOWEVER, NO EVIDENCE OF THROMBUS IN THE LEFT ATRIUM, PERICARDIAL EFFUSION AND ATRIAL SEPTAL SHUNT WERE NOTED. THE PATIENT WAS NOT ON ANY ANTIPLATELET ANTICOAGULANT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737182 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0023885101

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other