BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 4996699 · Received August 12, 2015

    Report

    Report Number
    2134265-2015-05403
    Event Type
    Death
    Date Received
    August 12, 2015
    Date of Event
    August 7, 2014
    Report Date
    July 17, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    EVOLUTION REGISTRY. SAME CASE AS MDR ID: 2134265-2015-05404. IT WAS REPORTED THAT A CEREBRAL AIR EMBOLISM AND PATIENT DEATH OCCURRED. IN (B)(6) 2014 A 27MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. A WATCHMAN ACCESS SYSTEM WAS ADVANCED AND USED SUCCESSFULLY. A 27MM WATCHMAN LAA CLOSURE DEVICE WAS THEN DEPLOYED AND RELEASED SUCCESSFULLY. NO RECAPTURE ATTEMPTS WERE MADE. THE DEVICE WAS PLACED DISTAL TO AND SPANNED THE ENTIRE LAA OSTIUM. A COMPLETE SEAL WAS NOTED. THERE WERE NO CONCOMITANT PROCEDURES PERFORMED. A PERIPROCEDURAL CEREBRAL ISCHEMIA WAS NOTED. THE PATIENT WAS REFERRED POST-INTERVENTION TO THE INTENSIVE CARE UNIT (ICU) IN A COMATOSE STATE WITH NO REACTION OR SPONTANEOUS MOTOR FUNCTIONS. COMPUTERIZED CRANIAL TOMOGRAPHY (CCT) PERFORMED FOUR HOURS AFTER INTERVENTION NOTED SEVERAL AIR BUBBLES IN BOTH CRANIAL HEMISPHERES. DUE TO PATIENT HISTORY AND COMPUTERIZED TOMOGRAPHY (CT) MORPHOLOGY IT IS ASSUMED THAT THE PATIENT SUFFERED FROM A MASSIVE AIR EMBOLISM. AFTER ADMISSION TO THE ICU, THE PATIENT SHOWED NO CHANGE AND REMAINED IN A DEEP COMATOSE STATE. PER NEUROLOGIST'S ASSESSMENT IT WAS ASSUMED THAT THE PATIENT SUFFERED FROM HEAVY HYPOXIC BRAIN DAMAGE. NO FURTHER INTENSIVE CARE MEASUREMENTS WERE PERFORMED AND THE PATIENT WAS EXTUBATED. ON (B)(6) 2014 THE PATIENT DIED WITHOUT REANIMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528368 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WS27060 16738583

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death