BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 7466167 · Received April 26, 2018

    Report

    Report Number
    2134265-2018-03577
    Event Type
    Death
    Date Received
    April 26, 2018
    Date of Event
    March 29, 2018
    Report Date
    March 29, 2018
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NGV
    UDI-DI
    08714729838234
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION CONCLUSION IS DEVICE NOT RETURNED AS THE COMPLAINT DID NOT INCLUDE RETURNED DEVICE REVIEW AND LACKED THE OBJECTIVE EVIDENCE OR DESCRIPTIVE CONDITIONS OF THE EVENT REQUIRED TO DETERMINE WHAT COULD HAVE CONTRIBUTED TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DEATH OCCURRED. THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. THE ANATOMY WAS WINDSOCK SHAPED. AT THE TIME OF THE TRANSSEPTAL CROSSING (15:33 PM) THE PATIENT'S ACTIVATED CLOTTING TIME WAS 400 SEC. A 24 MM WATCHMAN LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED AFTER ASSESSMENT AND PASSING OF ALL RELEASE CRITERIA (15:50 PM). FOLLOWING RELEASE THE PATIENT WAS STABLE AND THERE WAS NO EVIDENCE OF EFFUSION. IMMEDIATELY FOLLOWING THE LAA CLOSURE PROCEDURE, THE PATIENT REMAINED IN THE LAB AND UNDERWENT AV (ATRIOVENTRICULAR) NODE ABLATION. AT 16:09 PM, THE PATIENT'S HEART RATE HAD SIGNIFICANTLY DROPPED. THEY ADMINISTERED CARDIOPULMONARY RESUSCITATION (CPR) FOR THE NEXT HOUR AND CALLED CODE AT 17:11 PM.. THE DOCUMENTED CAUSE OF DEATH HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308968 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - GALWAY M635WU24060 0020458929 08714729838234

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death