BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 18368403 · Received December 20, 2023

    Report

    Report Number
    2124215-2023-71021
    Event Type
    Injury
    Date Received
    December 20, 2023
    Date of Event
    December 12, 2023
    Report Date
    April 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A6: RACE ADDED B2: OUTCOME ADDED B5: ADDITIONAL INFORMATION ADDED D6B: EXPLANT DATE ADDED H6: PATIENT CODES AND IMPACT CODE ADDED H6: CONCLUSION CODE UPDATED TO KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    HEAL-LAA STUDY WITH PATIENT IDENTIFIER (B)(6) IT WAS REPORTED THAT A DEVICE MOVEMENT OCCURRED. ON 31 OCTOBER 2023, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 35MM WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS) AND A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS). ON (B)(6) 2023, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED THE CLOSURE DEVICE HAD UNDERGONE A PROXIMAL MIGRATION AND WAS AFFECTING MITRAL VALVE FUNCTION. THE PATIENT IS SCHEDULED TO UNDERGO SURGICAL REVASCULARIZATION DUE TO CORONARY ARTERY DISEASE DURING WHICH THE CLOSURE DEVICE WILL BE EXPLANTED AND AN LAA CLIP PLACED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE PATIENT WAS HOSPITALIZED DUE TO MILD SHORTNESS OF BREATH ASSOCIATED WITH RAPID HEART RATE, THE DISPLACED 35MM WATCHMAN FLX PRO LAA CLOSURE DEVICE, AND CORONARY ARTERY DISEASE OF THE LEFT ANTERIOR DESCENDING ARTERY WITH 90% OCCLUSION. LAB TESTS WERE PERFORMED AND THE PATIENT UNDERWENT BILATERAL SELECTIVE CORONARY ANGIOGRAPHY AND LEFT HEART CATHETERIZATION. THORACIC ANGIOGRAM WAS PERFORMED IN THE LEFT ATRIUM OSTIUM PROJECTION AND FLUOROSCOPY WAS PERFORMED IN MULTIPLE PROJECTIONS TO ASSESS THE LOCATION OF THE 35MM WATCHMAN FLX PRO CLOSURE DEVICE. THE ANGIOGRAPHY RESULTS REVEALED HIGH-GRADE LEFT ANTERIOR DESCENDING DISEASE, TRACE AORTIC INSUFFICIENCY, NORMAL LEFT VENTRICULAR END-DIASTOLIC PRESSURE AND A 35MM WATCHMAN FLX PRO LAA CLOSURE DEVICE IN THE LEFT ATRIUM SUPERIOR TO THE MITRAL VALVE. THORACIC AORTOGRAPHY RESULTS SHOWED TRIVIAL AORTIC INSUFFICIENCY. FLUOROSCOPY ANALYSIS SHOWED THE 35MM WATCHMAN FLX PRO LAA CLOSURE DEVICE IN THE MID-LEFT ATRIUM, SITTING JUST ABOVE THE MITRAL VALVE WITH NO EVIDENCE THAT IT WAS IN THE LEFT VENTRICLE. THE PATIENT WAS EVALUATED BY CARDIOLOGY AND ELECTROPHYSIOLOGY DEPARTMENTS AND UNDERWENT EXPLANT OF THE 35MM WATCHMAN FLX PRO LAA CLOSURE DEVICE AS WELL AS LEFT ATRIAL APPENDAGE RESECTION AND REPAIR OF MITRAL VALVE PERFORATION. THE EVENT WAS NOTED TO BE RESOLVED.

    Description of Event or Problem · 0

    HEAL-LAA STUDY WITH PATIENT IDENTIFIER 2051LAA014. IT WAS REPORTED THAT A DEVICE MOVEMENT OCCURRED. ON (B)(6) 2023, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 35MM WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS) AND A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS). ON (B)(6) 2023, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED THE CLOSURE DEVICE HAD UNDERGONE A PROXIMAL MIGRATION AND WAS AFFECTING MITRAL VALVE FUNCTION. THE PATIENT IS SCHEDULED TO UNDERGO SURGICAL REVASCULARIZATION DUE TO CORONARY ARTERY DISEASE DURING WHICH THE CLOSURE DEVICE WILL BE EXPLANTED AND AN LAA CLIP PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297814 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION WS6035 0032256350 00191506004620

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other| H