BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX?

    MDR report key: 21908258 · Received April 25, 2025

    Report

    Report Number
    2124215-2025-26193
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    April 16, 2025
    Report Date
    April 25, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860495
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED AS 04/16/2025 AS THE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS 16 APRIL 2025. D4 UNIQUE IDENTIFIER (UDI) #: 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 THE 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: EVELYN GOODYEAR, AARON KUNAMALLA, ENRICO G. FERRO, RONUK M. MODI, ANDRE DAVILA, ANDREW H. LOCKE, DAVID LIU, ROGER J. LAHAM, SUCCESSFUL PERCUTANEOUS EXTRACTION OF A WATCHMAN FLX DEVICE FROM THE LEFT VENTRICULAR OUTFLOW TRACT, JACC: CASE REPORTS, VOLUME 30, ISSUE 8, 2025, 103186, ISSN 2666-0849, HTTPS://DOI.ORG/10.1016/J.JACCAS.2024.103186.

    Additional Manufacturer Narrative · 0

    B5: CORRECTION ADDED - THE EVENT NOTED IN THIS JOURNAL ARTICLE WAS PREVIOUSLY REPORTED TO BOSTON SCIENTIFIC AND CAPTURED IN REPORT NUMBER 2124215-2024-46601.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE IT WAS REPORTED DEVICE EMBOLIZATION OCCURRED. A 77-YEAR-OLD FEMALE PATIENT PRESENTED TO THE OUTPATIENT CARDIOLOGY OFFICE FOR A ROUTINE 45-DAY POST IMPLANT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) FOLLOWING AN UNCOMPLICATED 24MM WATCHMAN FLX CLOSURE DEVICE IMPLANTATION AT AN OUTSIDE HOSPITAL. THE TEE SHOWED THAT THE WATCHMAN CLOSURE DEVICE HAD MIGRATED TO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). NO EFFUSION WAS PRESENT. THE DEVICE APPEARED TO BE FREELY MOBILE BUT HAD NOT EMBOLIZED THROUGH THE AORTIC VALVE APPARATUS. THE PATIENT DENIED ANY SYMPTOMS. PHYSICAL EXAM WAS UNREMARKABLE WITH THE EXCEPTION OF A III/VI CRESCENDO-DECRESCENDO SYSTOLIC MURMUR AUSCULTATED OVER THE LEFT LOWER STERNAL BORDER. THERE WAS NO EVIDENCE OF CLINICAL HEART FAILURE OR EMBOLIC PHENOMENA. PERCUTANEOUS EXTRACTION WAS PERFORMED USING A NOVEL TECHNIQUE WITH RAT TOOTH/ALLIGATOR FORCEPS TO SUCCESSFULLY RETRIEVE THE WATCHMAN FROM THE LVOT USING A TRANSAORTIC APPROACH. A RAT TOOTH/ALLIGATOR GRASPING FORCEPS WITHIN THE SHUTTLE SHEATH WAS USED TO GRIP THE WATCHMAN, AND THE DEVICE WAS RETRIEVED TO THE DESCENDING AORTA. ANOTHER RAT TOOTH/ALLIGATOR GRASPING FORCEPS, INSERTED THROUGH THE COOK SHEATH, WAS USED TO SECURE THE DEVICE AT TWO (2) SEPARATE POINTS FOR STABILITY BEFORE RETRIEVAL INTO THE SHEATH. THE WATCHMAN DEVICE WAS THEN PULLED INTO THE SHEATH AND OUT OF THE BODY. THE PATIENT TOLERATED THE PROCEDURE WELL, AND NO POSTOPERATIVE COMPLICATIONS WERE NOTED. POSTOPERATIVE ECHOCARDIOGRAM THE FOLLOWING DAY DEMONSTRATED NO STRUCTURAL CARDIAC DAMAGE AND NO PERICARDIAL EFFUSION, ALONG WITH UNCHANGED FROM PRIOR MODERATE AORTIC STENOSIS AND MODERATE AORTIC REGURGITATION.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED DEVICE EMBOLIZATION OCCURRED. A 77-YEAR-OLD FEMALE PATIENT PRESENTED TO THE OUTPATIENT CARDIOLOGY OFFICE FOR A ROUTINE 45-DAY POST IMPLANT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) FOLLOWING AN UNCOMPLICATED 24MM WATCHMAN FLX CLOSURE DEVICE IMPLANTATION AT AN OUTSIDE HOSPITAL. THE TEE SHOWED THAT THE WATCHMAN CLOSURE DEVICE HAD MIGRATED TO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). NO EFFUSION WAS PRESENT. THE DEVICE APPEARED TO BE FREELY MOBILE BUT HAD NOT EMBOLIZED THROUGH THE AORTIC VALVE APPARATUS. THE PATIENT DENIED ANY SYMPTOMS. PHYSICAL EXAM WAS UNREMARKABLE WITH THE EXCEPTION OF A III/VI CRESCENDO-DECRESCENDO SYSTOLIC MURMUR AUSCULTATED OVER THE LEFT LOWER STERNAL BORDER. THERE WAS NO EVIDENCE OF CLINICAL HEART FAILURE OR EMBOLIC PHENOMENA. PERCUTANEOUS EXTRACTION WAS PERFORMED USING A NOVEL TECHNIQUE WITH RAT TOOTH/ALLIGATOR FORCEPS TO SUCCESSFULLY RETRIEVE THE WATCHMAN FROM THE LVOT USING A TRANSAORTIC APPROACH. A RAT TOOTH/ALLIGATOR GRASPING FORCEPS WITHIN THE SHUTTLE SHEATH WAS USED TO GRIP THE WATCHMAN, AND THE DEVICE WAS RETRIEVED TO THE DESCENDING AORTA. ANOTHER RAT TOOTH/ALLIGATOR GRASPING FORCEPS, INSERTED THROUGH THE COOK SHEATH, WAS USED TO SECURE THE DEVICE AT TWO (2) SEPARATE POINTS FOR STABILITY BEFORE RETRIEVAL INTO THE SHEATH. THE WATCHMAN DEVICE WAS THEN PULLED INTO THE SHEATH AND OUT OF THE BODY. THE PATIENT TOLERATED THE PROCEDURE WELL, AND NO POSTOPERATIVE COMPLICATIONS WERE NOTED. POSTOPERATIVE ECHOCARDIOGRAM THE FOLLOWING DAY DEMONSTRATED NO STRUCTURAL CARDIAC DAMAGE AND NO PERICARDIAL EFFUSION, ALONG WITH UNCHANGED FROM PRIOR MODERATE AORTIC STENOSIS AND MODERATE AORTIC REGURGITATION. THE EVENT NOTED IN THIS JOURNAL ARTICLE WAS PREVIOUSLY REPORTED TO BOSTON SCIENTIFIC AND CAPTURED IN REPORT NUMBER 2124215-2024-46601.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288998 WATCHMAN FLX? SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU50240 08714729860495

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Hospitalization| R