BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 19702000 · Received July 9, 2024

    Report

    Report Number
    2124215-2024-41777
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    April 12, 2024
    Report Date
    July 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED AS 04/12/2024 AS THE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS 12 APRIL 2024. CITATION: PATEL MM, PRABHAKAR S, OOSTRA C, RAMANATHAN PK. PERCUTANEOUS RETRIEVAL OF AN EMBOLIZED WATCHMAN DEVICE ON A PAPILLARY MUSCLE IN THE LEFT VENTRICLE. CATHETER CARDIOVASC INTERV. 2024; 103: 1152-1155. DOI:10.1002/CCD.31049.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT DEVICE EMBOLIZATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED, AND A 24MM WATCHMAN CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED THE NEXT MORNING THAT SHOWED EMBOLIZATION OF THE WATCHMAN DEVICE TO THE LEFT VENTRICLE (LV) AND SEEMED TO BE CAUGHT ONTO A PAPILLARY MUSCLE. IT WAS THEN DECIDED TO RETRIEVE THE DEVICE PERCUTANEOUSLY. THE RIGHT COMMON FEMORAL ARTERY AND RIGHT FEMORAL VEIN WERE BOTH ACCESSED. A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED TO VISUALIZE THE DEVICE. THE ORIGINAL TRANSSEPTAL PUNCTURE SITE WAS USED AGAIN TO PLACE A SHEATH IN THE LEFT ATRIUM. THE INITIAL APPROACH WAS TO SNARE THE WATCHMAN DEVICE RETROGRADELY VIA A RAPTOR GRASPING DEVICE; HOWEVER, THE ANGLE WAS NOT FAVORABLE AND THAT WAS UNSUCCESSFUL. A PIGTAIL CATHETER WAS UTILIZED VIA THE SHEATH ACROSS TRANSSEPTAL PUNCTURE TO DISLODGE THE DEVICE FROM THE LV; HOWEVER, THAT WAS UNSUCCESSFUL AS WELL. A GUIDE CATHETER WAS THEN TAKEN RETROGRADE TO THE LV IN AN ATTEMPT TO USE THE RAPTOR GRASPING DEVICE TO SNARE THE DEVICE WHICH WAS ALSO UNSUCCESSFUL. EVEN AFTER ATTEMPTING TO LENGTHEN THE GUIDE CATHETER, THE DEVICE WAS ATTACHED TO THE WALL FIRMLY AND WOULD NOT DISLODGE. A 100 CM 6 FRENCH SHEATH WAS TAKEN INTO THE LV WITH A 30MM GOOSENECK SNARE. THROUGH THE TRANSSEPTAL ACCESS, A SAFARI WIRE WAS TAKEN THROUGH A PIGTAIL AND BOTH WIRE AND CATHETER WERE THEN WRAPPED AROUND THE WATCHMAN DEVICE IN THE LV. USING BOTH THE WIRE AND CATHETER, THE WATCHMAN DEVICE WAS SUCCESSFULLY DISLODGED FROM THE LV. THE DEVICE WAS SAFELY GUIDED INTO THE DESCENDING AORTA AND THE RAPTOR SNARE GRABBED ONTO THE DEVICE. THE SNARE SAFELY GUIDED THE DEVICE BACK INTO THE 18 FRENCH SHEATH. THE WATCHMAN DEVICE WAS COMPRESSED COMPLETELY INTO THE SHEATH AND THEN REMOVED FROM THE BODY. THE PATIENT WAS SEEN IN FOLLOW UP AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390872 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention