BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 22114956 · Received May 30, 2025

    Report

    Report Number
    2124215-2025-35121
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    April 24, 2025
    Report Date
    October 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT - ARTICLE PUBLISH DATE USED AS EVENT DATE IS UNKNOWN. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LITERATURE CITATION: GARAPATI, S. S., BHUGRA, P., AMIN, M., ASEMOTA, I. R., NA, J., FAHED, J., & VALDERRABANO, M. (2025). WATCH THE STRUT: A RARE CASE OF LATE INTRADEVICE LEAK DUE TO A LEFT ATRIAL APPENDAGE OCCLUSION DEVICES LARGE STRUT FRACTURE. HEART RHYTHM, 22(4), S146-S147.

    Additional Manufacturer Narrative · 0

    H6 IMPACT CODES: IMAGING REQUIRED F2203 ADDED. B3 DATE OF EVENT - ARTICLE PUBLISH DATE USED AS EVENT DATE IS UNKNOWN. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LITERATURE CITATION: GARAPATI, S. S., BHUGRA, P., AMIN, M., ASEMOTA, I. R., NA, J., FAHED, J., & VALDERRABANO, M. (2025). WATCH THE STRUT: A RARE CASE OF LATE INTRADEVICE LEAK DUE TO A LEFT ATRIAL APPENDAGE OCCLUSION DEVICES LARGE STRUT FRACTURE. HEART RHYTHM, 22(4), S146-S147.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT THE DEVICE DID NOT SEAL, AND DEVICE FRACTURE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. THERE WAS NO INITIAL LEAK, AND THE DEVICE WAS SEATED WELL. TRANSESOPHAGEAL ECHOCARDIOGRAMS (TEE) DONE AT 45 DAYS, 6 MONTHS AND 1 YEAR LATER SHOWED NO EVIDENCE OF LEAK, BREAK OR THROMBOSIS IN ALL THE VIEWS. SIX YEARS LATER, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND AN ECHOCARDIOGRAM AND CARDIAC MRI SHOWED FLOW INTO THE LEFT ATRIAL APPENDAGE WITH CONTRAST ENHANCEMENT. A TEE CONFIRMED THAT THERE WAS A CLOSURE DEVICE STRUT FRACTURE WITH A LARGE INTRA DEVICE LEAK (7MM HIGH VELOCITY JET).

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE: IT WAS REPORTED THAT THE DEVICE DID NOT SEAL, AND DEVICE FRACTURE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. THERE WAS NO INITIAL LEAK, AND THE DEVICE WAS SEATED WELL. TRANSESOPHAGEAL ECHOCARDIOGRAMS (TEE) DONE AT 45 DAYS, 6 MONTHS AND 1 YEAR LATER SHOWED NO EVIDENCE OF LEAK, BREAK OR THROMBOSIS IN ALL THE VIEWS. SIX YEARS LATER, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND AN ECHOCARDIOGRAM AND CARDIAC MRI SHOWED FLOW INTO THE LEFT ATRIAL APPENDAGE WITH CONTRAST ENHANCEMENT. A TEE CONFIRMED THAT THERE WAS A CLOSURE DEVICE STRUT FRACTURE WITH A LARGE INTRA DEVICE LEAK (7MM HIGH VELOCITY JET).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579291 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other