BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 7125584 · Received December 18, 2017

    Report

    Report Number
    2134265-2017-12900
    Event Type
    Death
    Date Received
    December 18, 2017
    Date of Event
    October 5, 2017
    Report Date
    December 5, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NGV
    UDI-DI
    08714729838241
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE IN (B)(6) 2017, WHERE A 27MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY WAS IMPLANTED. SIX DAYS POST IMPLANTATION; THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A GASTROINTESTINAL BLEED (GI) AND HAD ALSO BEEN EXPERIENCING END STAGE RENAL DISEASE. AN ECHOCARDIOGRAM WAS COMPLETED AND WAS UNREMARKABLE. SEVENTEEN DAYS LATER, THE PATIENT WAS DISCHARGED AND DIED THAT AFTERNOON. THE CAUSE OF DEATH IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903480 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - GALWAY M635WU27060 0020289545 08714729838241

    Patients

    Seq Age Sex Outcome Treatment
    1