BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 5084746 · Received September 17, 2015

    Report

    Report Number
    2134265-2015-06151
    Event Type
    Death
    Date Received
    September 17, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 20, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    SAME CASE AS MDR ID: 2134265-2015-06152. IT WAS REPORTED THAT PERICARDIAL EFFUSION OCCURRED AND THE PATIENT EXPIRED. THE PATIENT WAS UNDERGOING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) MEASUREMENTS WERE OBTAINED. FLUOROSCOPY THEN REVEALED THE APPENDAGE WAS LARGER THAN THE TEE SUGGESTED, WITH TWO LOBES; THE ANTERIOR LOBE BEING THE LARGER OF THE TWO. TRANSSEPTAL PUNCTURE WAS PERFORMED AND THE WATCHMAN ACCESS SYSTEM (WAS) ADVANCED WITHOUT INCIDENT. THE PIGTAIL CATHETER WAS INITIALLY PLACED IN THE SMALLER POSTERIOR LOBE, BUT ULTIMATELY THE PIGTAIL CATHETER WAS PLACED IN THE LARGER ANTERIOR LOBE AND POSITIONED AT THE MID MARKER BAND FOR DEPLOYMENT. NO IMAGES WERE TAKEN OF WAS PLACEMENT. DURING THE INSERTION OF THE 27MM WATCHMAN CLOSURE DEVICE AND DELIVERY SYSTEM, THE WAS MOVED FORWARD CAUSING A PERFORATION IN THE APPENDAGE, VISUALIZED BY CONTRAST DYE. THE STAFF BEGAN PREPARATION FOR A PERICARDIOCENTESIS AND THE ECHO CARDIOLOGIST BEGAN TO MONITOR THE PROGRESS OF ANTICIPATED PERICARDIAL EFFUSION. THE WAS PULLED BACK SLIGHTLY AND THE WATCHMAN CLOSURE DEVICE WAS THEN DEPLOYED. FLUOROSCOPY CONFIRMED THE DEPLOYMENT OF THE DEVICE WAS DISTAL AND CONTRAST EXTRAVASATION INTO THE PERICARDIAL SPACE WAS NOTED. AFTER PULLING THE WATCHMAN BACK AND REDEPLOYING, THE CLOSURE DEVICE SEEMED TO COVER THE OSTIUM OF THE APPENDAGE. TEE MEASUREMENTS WERE OBTAINED AND A TUG TEST WAS PERFORMED SUCCESSFULLY, FOLLOWED BY SUBSEQUENT RELEASE OF THE DEVICE. THE EFFUSION HAD GROWN MINIMALLY, BUT SEEMED TO BE MANAGEABLE. BLOOD WAS BEING DRAINED FROM THE PERICARDIAL SPACE AND AFTER SOME TIME, THE BLOOD STOPPED DRAINING. THE PHYSICIAN CHANGED OUT THE EFFUSION CATHETER FOR A PIGTAIL CATHETER AND THEN ULTIMATELY PLACED A SHEATH TO ATTEND TO FLUID DRAINAGE TO NO AVAIL. THE PATIENT WAS PREPPED FOR SURGERY AS THE BLOOD PRESSURE HAD BECOME MORE UNSTABLE. THE PATIENT ULTIMATELY EXPIRED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615444 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WU27060 16485510

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death| R