BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 12623905 · Received October 13, 2021

    Report

    Report Number
    2134265-2021-12818
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    January 1, 2020
    Report Date
    October 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: ESTIMATED SINCE UNKNOWN. TORRES-SAURA, FRANCISCO, ET. AL. "CATHETER-BASED CLOSURE OF MULTIPLE RESIDUAL LEAKS AFTER PERCUTANEOUS LEFT ATRIAL APPENDAGE OCCLUSION WITH THE WATCHMAN DEVICE" PORTUGUESE JOURNAL OF CARDIOLOGY, 2020; 39(8):476-478.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE THAT A STROKE OCCURRED AND THE IMPLANT DID NOT SEAL. A LEFT ATRIAL APPENDAGE (LAA) PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. IT WAS NOTED THERE WAS A SMALL LEAK OF LESS THAN 3MM THAT WAS MANAGED CONSERVATIVELY. TWO YEARS AFTER THE IMPLANT, THE PATIENT SUFFERED A NEW EPISODE OF ISCHEMIC STROKE IN THE FRONTAL LOBE. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED THE PRESENCE OF TWO LEAKS GREATER THAN 5MM. ONE WAS ON THE POSTEROSUPERIOR SIDE AND THE OTHER ON THE ANTEROINFERIOR. DUE TO HIGH HEMORRHAGIC RISK, THE PATIENT UNDERWENT PERCUTANEOUS CLOSURE OF THE LEAKS. TWO NON-BOSTON SCIENTIFIC VASCULAR PLUGS WERE IMPLANTED TO CLOSE THE LEAKS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519608 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention