BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 20362590 · Received October 3, 2024

    Report

    Report Number
    2124215-2024-61974
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    September 26, 2024
    Report Date
    November 18, 2024
    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

    Additional Manufacturer Narrative · 0

    B5: CORRECTION ADDED. H6: PATIENT CODES CORRECTED FROM THROMBOSIS/THROMBUS TO NO CLINICAL SIGNS SYMPTOMS OR CONDITIONS. H6: IMPACT CODE CORRECTED FROM MEDICATION REQUIRED TO NO HEALTH CONSEQUENCE OR IMPACT.

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY ON (B)(6) 2024 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WITH SUCCESSFUL PLACEMENT OF A 31MM WATCHMAN FLX PRO LAAC DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 22 MM. THE PATIENT WAS DISCHARGED THE SAME DAY. ON (B)(6) 2024, 83 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL SCHEDULED 3 MONTH FOLLOW UP. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING ASSESSMENT WAS PERFORMED WHICH REVEALED A LAMINAR, NON-MOBILE DEVICE RELATED THROMBUS (DRT) ON THE ATRIAL SURFACE OF THE CLOSURE DEVICE WITH MAXIMUM AREA 0.33 CM. THE DEVICE WAS POSITIONED AT PROXIMAL TO OSTIUM (LESS THAN 1/3 OF DEVICE LENGTH PROXIMAL TO THE DESIRED OSTIAL PLANE). NO PERI-DEVICE LEAK WAS NOTED. THE PATIENT MEDICATION REGIME WAS CHANGED FROM DUAL ANTIPLATELET THERAPY (DAPT) TO APIXABAN.

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE HEAL-LAA STUDY ON (B)(6)2024 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WITH SUCCESSFUL PLACEMENT OF A 31MM WATCHMAN FLX PRO LAAC DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 22 MM. THE PATIENT WAS DISCHARGED THE SAME DAY. ON (B)(6) 2024, 83 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL SCHEDULED 3 MONTH FOLLOW UP. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING ASSESSMENT WAS PERFORMED WHICH REVEALED A LAMINAR, NON-MOBILE DEVICE RELATED THROMBUS (DRT) ON THE ATRIAL SURFACE OF THE CLOSURE DEVICE WITH MAXIMUM AREA 0.33 CM. THE DEVICE WAS POSITIONED AT PROXIMAL TO OSTIUM (LESS THAN 1/3 OF DEVICE LENGTH PROXIMAL TO THE DESIRED OSTIAL PLANE). NO PERI-DEVICE LEAK WAS NOTED. THE PATIENT MEDICATION REGIME WAS CHANGED FROM DUAL ANTIPLATELET THERAPY (DAPT) TO APIXABAN. IT WAS FURTHER CLARIFIED FROM THE CLINICAL SITE THAT THIS PATIENT UNDERWENT A TEE ON (B)(6) 2024 AND AT THAT TIME THE ECHOCARDIOLOGIST THOUGHT THAT THE PATIENT HAD A DEVICE RELATED THROMBOSIS (DRT) AND THEREFORE THE PATIENT'S ANTICOAGULANT/ANTIPLATELET THERAPY WAS CHANGED. THE CLINICAL STAFF ORDERED A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN TO GET BETTER IMAGING WHICH WAS COMPLETED ON (B)(6)2024. THE IMAGING ON THE CT SHOWED THAT THE PATIENT DID NOT HAVE A DEVICE RELATED THROMBOSIS BUT WAS DEVICE ASSOCIATED HYPOATTENUATED TISSUE/THICKENING ON ATRIAL SURFACE, THEREFORE THE COMPLAINT WAS WITHDRAWN. ONCE FOLLOW UP IMAGING CONFIRMED NO DRT, ON (B)(6)2024, APIXABAN WAS DISCONTINUED AND ON (B)(6) 2024, CLOPIDOGREL WAS RESTARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2608397 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION WS6031 0033695419 00191506004613

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other