BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN ACCESS SYSTEM

    MDR report key: 21586087 · Received March 12, 2025

    Report

    Report Number
    2124215-2025-15327
    Event Type
    Injury
    Date Received
    March 12, 2025
    Date of Event
    December 23, 2024
    Report Date
    March 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED AS 12/23/2024 AS THE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS 23 DECEMBER 2024. LITERATURE CITATION: JING ZHOU, ZONGQI ZHANG, KANDI ZHANG, TIANTIAN ZHANG, QING HE, JUNFENG ZHANG. COMPARATIVE ENDOTHELIALIZATION OF THE WATCHMAN PLUG DEVICE AND LACBES PACIFIER OCCLUDER AFTER LEFT ATRIAL APPENDAGE CLOSURE. REV. CARDIOVASC. MED. 2024, 25(12), 450. HTTPS://DOI.ORG/10.31083/J.RCM2512450.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE: IT WAS REPORTED THAT PERIPROCEDURAL PERIPHERAL VASCULAR COMPLICATIONS OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS PERFORMED, AND WATCHMAN LAA CLOSURE DEVICE(S) WERE IMPLANTED IN ONE HUNDRED ONE (101) PATIENTS. THE IMPLANTATION PROCEDURE WAS SUCCESSFUL IN ALL PATIENTS, WITHOUT ANY OBSERVED PERIPROCEDURAL COMPLICATIONS, SUCH AS CARDIAC TAMPONADE, STROKE OR TIA, OR DEVICE EMBOLIZATION. THERE WERE FOUR (4) PATIENTS REPORTED TO HAVE PERIPROCEDURAL PERIPHERAL VASCULAR COMPLICATIONS DURING THE LAAC PROCEDURE USING THE WATCHMAN LAA DEVICE(S). TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED THREE (3) MONTHS AFTER LAAC, AND A DEVICE RELATED THROMBUS (DRT) WAS DETECTED IN TWO (2) PATIENTS WITH THE WATCHMAN LAA CLOSURE DEVICE. DURING THE SIX (6) MONTHS CLINICAL FOLLOW UP, BLEEDING COMPLICATIONS WERE REPORTED TO HAVE OCCURRED IN THREE (3) PATIENTS THAT HAD THE WATCHMAN LAA CLOSURE DEVICE IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED IF ANY INTERVENTION WAS REQUIRED ON ANY OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112803 WATCHMAN ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other