BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 13231062 · Received January 11, 2022

    Report

    Report Number
    2134265-2021-16250
    Event Type
    Injury
    Date Received
    January 11, 2022
    Date of Event
    January 2, 2021
    Report Date
    January 11, 2022
    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

    IMPLANT DATE: ESTIMATED AS (B)(6) 2021 AS THE ARTICLE WAS PUBLISHED IN 2021 AND NO INITIAL DATE OF PROCEDURE WAS PROVIDED. EXPLANT DATE: ESTIMATED AS (B)(6) 2021 THE DATE OF EMBOLIZATION WAS NOTED AS ONE DAY POST PROCEDURE. DATE OF EVENT: ESTIMATED AS (B)(6) 2021 THE DATE OF EMBOLIZATION WAS NOTED AS ONE DAY POST PROCEDURE. LITERATURE CITATION: ENOMOTO Y, HARA H, KITANO S, SAITO S, HAYAMA H, AMEMIYA K, YAZAKI Y, NAKAMURA K, IIJIMA R, SUGI K, MOROI M, NAKAMURA M. SUCCESSFUL PERCUTANEOUS RETRIEVAL OF AN EMBOLIZED LEFT ATRIAL APPENDAGE CLOSURE DEVICE IN THE LEFT VENTRICULAR OUTFLOW TRACT. CIRC J. 2021 SEP 24;85(10):1893. DOI: 10.1253/CIRCJ.CJ-21-0469. EPUB 2021 JUL 2. PMID: 34219075.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT A DEVICE EMBOLIZATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 30MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. THE CLOSURE DEVICE EMBOLIZED INTO THE LEFT VENTRICULAR OUTFLOW TRACT ONE DAY POST INDEX PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND PERCUTANEOUS RETRIEVAL WAS PERFORMED BY SNARING THE CLOSURE DEVICE WITH TWO 25MM GOOSE NECK SNARE CATHETERS. A BETA BLOCKER WAS USED FOR LONGER DURATION OF AORTIC VALVE OPENING. AFTER THE CLOSURE DEVICE WAS CRUSHED VIA THE SNARES, THE CLOSURE DEVICE WAS RETRACTED FROM THE LEFT VENTRICLE INTO THE ASCENDING AORTA. THE CLOSURE DEVICE WAS PULLED BACK INTO THE AORTA AND REMOVED FROM THE PATIENT WITH NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584101 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10372

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention