BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 12143080 · Received July 9, 2021

    Report

    Report Number
    2134265-2021-08433
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    June 18, 2021
    Report Date
    September 29, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: B5.

    Description of Event or Problem · 0

    OPTION STUDY IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE PATIENT WAS ENROLLED INTO THE OPTION STUDY ON (B)(6) 2021 AND THE INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2021. THE PATIENT WAS ON ASPIRIN AND APIXABAN PRIOR TO IMPLANT WHICH WAS NOT INTERRUPTED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS ADMINISTERED. THE PATIENT WAS ABLATED USING THE PULMONARY VEIN ISOLATION WITH CRYO METHOD. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS THEN PERFORMED AND A 20MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 16.4 MM. AFTER THE IMPLANT THE PATIENT CONTINUED ON BOTH ASPIRIN AND APIXABAN. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. ON (B)(6) 2021, 86 DAYS POST INDEX PROCEDURE, DURING THE PROTOCOL SCHEDULED 3 MONTHS FOLLOW-UP VISIT, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 45%. A PEDUNCULATED NON-MOBILE THROMBUS WITH A MAXIMUM AREA OF 1 CM2 WAS FOUND ON THE ATRIAL FACING SURFACE OF THE WATCHMAN DEVICE. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN AND APIXABAN. THE PATIENT WAS STARTED ON CLOPIDOGREL. THE PATIENT IS ASYMPTOMATIC, WITH NO SHORTNESS OF BREATH AND NO FATIGUE. IT WAS FURTHER REPORTED THAT ON (B)(6) 2021, A REPEAT TEE WAS PERFORMED AND REVEALED NO THROMBUS ON THE WATCHMAN FLX DEVICE. ELIQUIS (APIXABAN) WAS DISCONTINUED AND THE EVENT WAS CONSIDERED RESOLVED.

    Description of Event or Problem · 1

    OPTION STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE PATIENT WAS ENROLLED INTO THE OPTION STUDY ON (B)(6) 2021 AND THE INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2021. THE PATIENT WAS ON ASPIRIN AND APIXABAN PRIOR TO IMPLANT WHICH WAS NOT INTERRUPTED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS ADMINISTERED. THE PATIENT WAS ABLATED USING THE PULMONARY VEIN ISOLATION WITH CRYO METHOD. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS THEN PERFORMED AND A 20MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 16.4 MM. AFTER THE IMPLANT THE PATIENT CONTINUED ON BOTH ASPIRIN AND APIXABAN. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. ON (B)(6) 2021, 86 DAYS POST INDEX PROCEDURE, DURING THE PROTOCOL SCHEDULED 3 MONTHS FOLLOW-UP VISIT, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 45%. A PEDUNCULATED NON-MOBILE THROMBUS WITH A MAXIMUM AREA OF 1 CM2 WAS FOUND ON THE ATRIAL FACING SURFACE OF THE WATCHMAN DEVICE. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN AND APIXABAN. THE PATIENT WAS STARTED ON CLOPIDOGREL. THE PATIENT IS ASYMPTOMATIC, WITH NO SHORTNESS OF BREATH AND NO FATIGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039927 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0026714228 08714729860488

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other