BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 18703365 · Received February 14, 2024

    Report

    Report Number
    2124215-2024-06997
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    January 25, 2024
    Report Date
    February 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT: AWARE DATE WAS USED AS EVENT DATE AS ACTUAL EVENT DATE WAS NOT KNOWN. LITERATURE CITATION: SHOJI T, ET AL. "ST-SEGMENT ELEVATION DURING PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE." J AM COLL CARDIOL CASE REP 2024;29:102216.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE IT WAS REPORTED VIA LITERATURE THAT ST SEGMENT ELEVATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED ON A PATIENT WITH WINDSOCK-SHAPED ANATOMY. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 31MM WATCHMAN FLX CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WAS INSERTED. THE 31MM WDS WAS DEPLOYED, HOWEVER DURING THE EVALUATION OF THE POSITION, ANCHOR, SIZE AND SEAL (PASS) CRITERIA, IT WAS NOTED THAT ONE-HALF OF THE SHOULDER OF THE DEVICE PROTRUDED ON THE POSTERIOR SIDE. THE PATIENT'S BLOOD PRESSURE DECREASED, AND ELECTROCARDIOGRAM (ECG) SHOWED ST SEGMENT ELEVATION. A REVIEW OF TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED AN INCREASE IN LEFT CORONARY ARTERY (LCA) BLOOD FLOW. THE 31MM WDS WAS RECAPTURED, AND THE PATIENT SYMPTOMS IMPROVED. THE PHYSICIAN ATTEMPTED TO REPOSITION THE 31MM WDS IN A DEEPER PART OF THE LAA, BUT ALSO OBSERVED THE DEVICE PROTRUDING ON THE POSTERIOR SIDE, AND SIMILAR ST-WAVE CHANGES WERE ALSO OBSERVED ON THE ECG. THE PHYSICIAN SUSPECTED THAT THE DEVICE WAS CAUSING A CORONARY ARTERY COMPRESSION AND DETERMINED THAT THE IMPLANTATION WOULD BE DIFFICULT IN THE PATIENT ANATOMY. THE PROCEDURE WAS DISCONTINUED. A SURGICAL RESECTION OF THE LAA WILL BE PERFORMED AT A LATER DATE. THE PATIENT REMAINED IN THE HOSPITAL FOR OBSERVATIONS AND WAS DISCHARGED ON THE FIFTH DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285252 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 70 YR Male Other| H