BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 13428188 · Received February 2, 2022

    Report

    Report Number
    2134265-2022-00999
    Event Type
    Injury
    Date Received
    February 2, 2022
    Date of Event
    December 29, 2021
    Report Date
    February 25, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6).

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6).

    Description of Event or Problem · 0

    (B)(6) STUDY. IT WAS REPORTED A TRANSIENT ISCHEMIC ATTACK OCCURRED. PRIOR TO THE PROCEDURE, THE PATIENT UNDERWENT ATRIAL FIBRILLATION ABLATION WITH PULMONARY VEIN ISOLATION USING CRYO METHOD. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 26 MM. AFTER THE IMPLANT PROCEDURE, THE PATIENT WAS STARTED ON ASPIRIN AND APIXABAN. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED. ON (B)(6) 2021, 357 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA). IT WAS NOTED THAT AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN. THE TIA EVENT WAS DIAGNOSED BY MAGNETIC RESONANCE IMAGING (MRI) WITH CONTRAST AND EXTRACRANIAL DUPLEX. ON THE SAME DAY, THE EVENT WAS NOTED TO HAVE BEEN RESOLVED.

    Description of Event or Problem · 0

    OPTION STUDY. IT WAS REPORTED A TRANSIENT ISCHEMIC ATTACK OCCURRED. PRIOR TO THE PROCEDURE, THE PATIENT UNDERWENT ATRIAL FIBRILLATION ABLATION WITH PULMONARY VEIN ISOLATION USING CRYO METHOD. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 26 MM. AFTER THE IMPLANT PROCEDURE, THE PATIENT WAS STARTED ON ASPIRIN AND APIXABAN. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED. ON (B)(6) 2021, 357 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA). IT WAS NOTED THAT AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN. THE TIA EVENT WAS DIAGNOSED BY MAGNETIC RESONANCE IMAGING (MRI) WITH CONTRAST AND EXTRACRANIAL DUPLEX. ON THE SAME DAY, THE EVENT WAS NOTED TO HAVE BEEN RESOLVED. ADDITIONAL INFORMATION REPORTED THAT ON (B)(6) 2022, A CRANIAL MRI WITH CONTRAST REVEALED OLD POSTISCHEMIC DEFECT IN THE RIGHT CEREBELLAR REGION, CLEAR VASCULAR ENCEPHALOPATHY WITHOUT ANY SIGNS OF FRESH ISCHEMIA, AND NO SPACE-OCCUPYING LESION. NO SEVERE STENOSES OF THE INTRACRANIAL VESSELS, HYPOPLASIA IN THE LEFT V4 SEGMENT IN THE COMPARISON OF THE SIDES. ORAL MEDICATION WAS ADJUSTED TO TREAT THE EVENT. DURING THIS TIME, THE PATIENT WAS RECOMMENDED TO CONTINUE ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103623 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0025703666

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other