BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 13239634 · Received January 12, 2022

    Report

    Report Number
    2134265-2021-16579
    Event Type
    Injury
    Date Received
    January 12, 2022
    Date of Event
    January 1, 2021
    Report Date
    January 12, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: ESTIMATED AS (B)(6) 2021 AS THE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS 02/09/2021. IMPLANT DATE: ESTIMATED AS (B)(6) 2021 AS THE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS 02/09/2021. (B)(6). LITERATURE CITATION: PRABHAKAR BHAT S, PATEL N R, SETHI N (FEBRUARY 09, 2021) SUCCESSFUL WATCHMAN DEVICE PLACEMENT DESPITE LEFT ATRIAL APPENDAGE PERFORATION IN TWO CASES. CUREUS 13(2): E13251. DOI 10.7759/CUREUS.13251.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT PERFORATION AND PERICARDIAL EFFUSION (PE) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. FEMORAL VEIN ACCESS WAS GAINED AND A 5-FRENCH ANGLED PIGTAIL CATHETER WAS INSERTED. INJECTION OF CONTRAST CONFIRMED THE SATISFACTORY POSITION OF THE PIGTAIL CATHETER AT THE LAA ORIFICE. UPON FURTHER ADVANCEMENT OF THE SHEATH, A SLIGHT STAINING OF THE PERICARDIUM WAS NOTICED, WHICH WORSENED OVER THE NEXT FEW MINUTES. TO PREVENT FURTHER PROGRESSION TO FRANK PE, THE DECISION WAS MADE TO DEPLOY THE WATCHMAN DEVICE. SATISFACTORY HEMOSTASIS WAS OBTAINED. TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED SATISFACTORY RESULTS WITH TRACE PERICARDIAL EFFUSION AND MINIMAL PERI-DEVICE LEAKAGE. THE PATIENT TOLERATED THE PROCEDURE WELL. THE NEXT DAY A LIMITED 2-DIMENTIONAL TRANSTHORACIC ECHOCARDIOGRAM REVEALED TRACE PE WITHOUT EVIDENCE OR CARDIAC TAMPONADE. THE PATIENT WAS DISCHARGED ON ASPIRIN AND COUMADIN. AT THE 45-DAY FOLLOW-UP, TEE REVEALED A WELL-SEATED WATCHMAN DEVICE WITH A SUPERIOR LEAK OF LESS THAN 1MM IN WIDTH. NO PE WAS VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738474 WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other