BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19928587 · Received August 7, 2024

    Report

    Report Number
    2124215-2024-48302
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    August 5, 2024
    Report Date
    October 3, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2: BSC AWARE DATE USED FOR EVENT DATE AS IT IS UNKNOWN. D6A: BSC AWARE DATE USED FOR IMPLANT DATE AS IT IS UNKNOWN. D6B: BSC AWARE DATE USED FOR EXPLANT DATE AS IT IS UNKNOWN. LITERATURE CITATION INCOMPLETE/UNKNOWN.

    Additional Manufacturer Narrative · 0

    H2: CORRECTION - THIS COMPLAINT WAS CONFIRMED TO BE A DUPLICATE OF EMDR REPORT NUMBER 2013265-2022-00153. THIS REPORT WILL CLOSED AS A DUPLICATE. H6: IMPACT CODE UPDATED FROM ADDITIONAL DEVICE REQUIRED TO NO HEALTH CONSEQUENCES OR IMPACT. H6: DEVICE CODE UPDATED FROM DEVICE DISLODGED OR DISLOCATED TO ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. H10: DUPLICATE EMDR REPORT NUMBER ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT DEVICE EMBOLIZATION OCCURRED. PREOPERATIVE CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) SHOWED CHICKEN-WING LEFT ATRIAL APPENDAGE (LAA), AND THE OSTIUM DIAMETER WAS 31MM. A LAA CLOSURE PROCEDURE WAS PERFORMED, AND A 35MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. AFTER THE PROCEDURE, CT REVEALED THE DISLODGEMENT OF THE CLOSURE DEVICE AS IT HAD EMBOLIZED INTO THE AORTIC ARC. A NON-BOSTON SCIENTIFIC SHEATH AND RETRIEVAL SYSTEM WAS USED TO PERCUTANEOUSLY RETRIEVE THE CLOSURE DEVICE SUCCESSFULLY. NO FURTHER INTERVENTIONS OR PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT DEVICE EMBOLIZATION OCCURRED. PREOPERATIVE CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) SHOWED CHICKEN-WING LEFT ATRIAL APPENDAGE (LAA), AND THE OSTIUM DIAMETER WAS 31MM. A LAA CLOSURE PROCEDURE WAS PERFORMED, AND A 35MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. AFTER THE PROCEDURE, CT REVEALED THE DISLODGEMENT OF THE CLOSURE DEVICE AS IT HAD EMBOLIZED INTO THE AORTIC ARC. A NON-BOSTON SCIENTIFIC SHEATH AND RETRIEVAL SYSTEM WAS USED TO PERCUTANEOUSLY RETRIEVE THE CLOSURE DEVICE SUCCESSFULLY. NO FURTHER INTERVENTIONS OR PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220484 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention