BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 19124969 · Received April 17, 2024

    Report

    Report Number
    2124215-2024-21824
    Event Type
    Injury
    Date Received
    April 17, 2024
    Date of Event
    May 15, 2020
    Report Date
    April 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 PATIENT CODES UPDATED. LITERATURE ARTICLE: SUN X, HONG D, LIU H, LI H. (2020) ACUTE MITRAL VALVE INJURY FOLLOWING PERCUTANEOUS LEFT ATRIAL APPENDAGE OCCLUSION: A CASE REPORT AND LITERATURE REVIEW. HEART SURG FORUM. 23(6): (B)(6).

    Additional Manufacturer Narrative · 0

    LITERATURE ARTICLE: SUN X, HONG D, LIU H, LI H. (2020) ACUTE MITRAL VALVE INJURY FOLLOWING PERCUTANEOUS LEFT ATRIAL APPENDAGE OCCLUSION: A CASE REPORT AND LITERATURE REVIEW. HEART SURG FORUM. 23(6): E743-E745. DOI:10.1532/HSF.3157.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT DEVICE EMBOLIZATION AND MITRAL VALVE INJURY OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 33MM WATCHMAN LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). FOLLOWING THE COMPLETION OF THE PROCEDURE, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND ANGIOGRAPHY REVEALED THE CLOSURE DEVICE HAD EMBOLIZED OUT OF THE LAA AND BECOME TRAPPED IN THE MITRAL VALVE RESULTING IN SEVERE MITRAL REGURGITATION AND HEMODYNAMIC INSTABILITY. THE PATIENT UNDERWENT EMERGENCY CARDIAC SURGERY. THE CLOSURE DEVICE WAS HOOKED TO THE MITRAL VALVE TENDON AND SEVERE DAMAGE TO THE MITRAL VALVE LEAFLETS HAD OCCURRED. THE CLOSURE DEVICE WAS REMOVED AND THE LAA WAS SURGICALLY CLOSED. THE DAMAGED MITRAL VALVE WAS SURGICALLY REPLACED WITH AN ARTIFICIAL VALVE. THE PATIENT FULLY RECOVERED AND WAS DISCHARGED TEN (10) DAYS POST INDEX PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT DEVICE EMBOLIZATION AND MITRAL VALVE INJURY OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 33MM WATCHMAN LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). FOLLOWING THE COMPLETION OF THE PROCEDURE, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND ANGIOGRAPHY REVEALED THE CLOSURE DEVICE HAD EMBOLIZED OUT OF THE LAA AND BECOME TRAPPED IN THE MITRAL VALVE RESULTING IN SEVERE MITRAL REGURGITATION AND HEMODYNAMIC INSTABILITY. THE PATIENT UNDERWENT EMERGENCY CARDIAC SURGERY. THE CLOSURE DEVICE WAS HOOKED TO THE MITRAL VALVE TENDON AND SEVERE DAMAGE TO THE MITRAL VALVE LEAFLETS HAD OCCURRED. THE CLOSURE DEVICE WAS REMOVED AND THE LAA WAS SURGICALLY CLOSED. THE DAMAGED MITRAL VALVE WAS SURGICALLY REPLACED WITH AN ARTIFICIAL VALVE. THE PATIENT FULLY RECOVERED AND WAS DISCHARGED TEN (10) DAYS POST INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975560 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10372

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention| H