BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 22028334 · Received May 15, 2025

    Report

    Report Number
    2124215-2025-31086
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    March 18, 2025
    Report Date
    May 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED AS 03/18/2025 AS THE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS 18 MARCH 2025. D4 MODEL NUMBER, D4 LOT NUMBER, D4 EXPIRATION DATE, D4 UNIQUE IDENTIFIER (UDI) # ARE UNKNOWN AS THE INFORMATION WAS NOT PROVIDED IN THE LITERATURE ARTICLE. LITERATURE CITATION: FRAZZETTO, M., YOON, S.H., & FILBY, S.J. (2025). CLINICAL IMPLICATIONS FOR FABRIC LEAK AFTER WATCHMAN FLX DEVICE IMPLANTATION: A STUDY UPDATE. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS. HTTPS://DOI.ORG/10.1002/CCD.31494.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT THE DEVICE DID SEAL AND STROKE, SYSTEMIC EMBOLISM (SE) OR TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. THE PURPOSE OF THIS STUDY WAS TO ASSESS THE POSSIBLE CLINICAL IMPLICATIONS FOR A FABRIC LEAK AFTER WATCHMAN FLX DEVICE IMPLANTATION. THE RESULTS OF A 45-DAY COMPUTED TOMOGRAPHY (CT) SCAN ON PATIENT WITH A WATCHMAN FLX DEVICE SURVEILLANCE WERE REPORTED AND FOLLOWING 1 YEAR CT SCAN IN THOSE WHO HAD RESIDUAL LEFT ATRIAL APPENDAGE (LAA) PATENCY IN 105 CONSECUTIVE PATIENTS FEBRUARY 2021 TO MARCH 2022. A TOTAL OF 14 (13.3%) CASES OF DISTAL LAA PATENCY WERE REPORTED, WHICH WAS DEFINED AS "MACCHIATO SIGN" BUT IT IS NOW WELL KNOWN AS WATCHMAN FLX "FABRIC LEAK" (FL). IT IS DEFINED AS THE DISTAL OPACIFICATION OF THE LAA DESPITE THE ABSENCE OF VISIBLE COMMUNICATION BETWEEN THE LEFT ATRIUM AND LAA AND IS ATTRIBUTABLE TO A TILTED DEVICE WHICH RESULTS IN LEAKAGE WITH BLOOD FLOW INTO THE LAA BENEATH THE FABRIC MEMBRANE. THE CLINICAL SIGNIFICANCE OF FABRIC LEAK IS CURRENTLY UNKNOWN. THEREFORE, WE DECIDED TO INVESTIGATE AT THE LONGEST AVAILABLE FOLLOW UP THE RATE OF CLINICAL EVENTS FOR THE THREE GROUPS OF OUR STUDY (COMPLETELY SEALED [CS] [N = 70], COMPLETELY PATENT [CP] [N = 21] AND FABRIC LEAK (FL) [N = 14]). THE PRIMARY COMPOSITE ENDPOINT OF STROKE, SYSTEMIC EMBOLISM (SE) OR TRANSIENT ISCHEMIC ATTACK (TIA) ALL CAUSE DEATH AND NONPROCEDURAL MAJOR BLEEDING WERE REPORTED USING THE KAPLAN MEIER ESTIMATE CURVES TO PRESENT THE CLINICAL OUTCOMES OVER TIME, AND CURVES WERE COMPARED USING THE LOG RANK TEST. FOR THE PRIMARY COMPOSITE ENDPOINT, HRS WERE COMPUTED FOR THE COMPARISON BETWEEN GROUPS. P VALUES < 0.05 WERE CONSIDERED THE THRESHOLD FOR STATISTICAL SIGNIFICANCE. OVER A MEDIAN FOLLOW-UP OF 3.1 YEARS, THE PRIMARY COMPOSITE OF STROKE, SYSTEMIC EMBOLISM (SE), OR TRANSIENT ISCHEMIC ATTACK (TIA) WERE HIGHER IN THE FL AND CP GROUPS COMPARED TO THE CS GROUP. COMPLETELY SEALED (CS) GROUP (70 PATIENTS): STROKE, SE, OR TIA: 2.8%. NON-PROCEDURAL MAJOR BLEEDING: 5.7%. ALL-CAUSE DEATH: 7.2%. COMPLETELY PATENT (CP) GROUP (21 PATIENTS): STROKE, SE, OR TIA: 14.28%. NON-PROCEDURAL MAJOR BLEEDING: 4.76%. ALL-CAUSE DEATH: 9.5%. FABRIC LEAK (FL) GROUP (14 PATIENTS): STROKE, SE, OR TIA: 14.28%. NON-PROCEDURAL MAJOR BLEEDING: 7.14%. ALL-CAUSE DEATH: 14.3%. OF NOTE, ONE (1) CASE OF STROKE OCCURRED 99 DAYS AFTER THE INDEX PROCEDURE IN A PATIENT WITH FL AT 45 DAYS AND SUBSEQUENT COMPLETE SEALING OF THE LAA AT 1 YEAR CT SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833024 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other