BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN® ACCESS SYSTEM

    MDR report key: 7125881 · Received December 18, 2017

    Report

    Report Number
    2134265-2017-12768
    Event Type
    Death
    Date Received
    December 18, 2017
    Date of Event
    December 7, 2017
    Report Date
    December 7, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NGV
    UDI-DI
    08714729838203
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2017-12767. IT WAS REPORTED A PERFORATION AND PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN® ACCESS SYSTEM (WAS) WAS POSITIONED IN THE LAA. A 27MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS ADVANCED AND THE CLOSURE DEVICE WAS DEPLOYED. RELEASE CRITERIA WAS BEING ASSESSED AND AFTER THE TUG TEST, THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS SEEN ON ECHOCARDIOGRAM. A PERICARDIAL DRAIN WAS PLACED AND MEDICATION WAS ADMINISTERED; THE PATIENT STABILIZED. ULTIMATELY THE PATIENT WENT TO SURGERY. DURING SURGERY THEY FOUND THAT ONE OF THE ANCHORS FROM THE SIDE OF THE DEVICE HAD PUNCTURED THE LAA CAUSING THE EFFUSION. THE DEVICE WAS REMOVED, THE PERFORATION WAS REPAIRED AND THE APPENDAGE WAS CLIPPED SURGICALLY. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT IN STABLE CONDITION.

    Description of Event or Problem · 1

    IT WAS FURTHER CLARIFIED THAT THE DEVICE WAS NEVER RELEASED. IT WAS FULLY RECAPTURED AND REMOVED PRIOR TO THE LAA CLIPPING. IT WAS LATER REPORTED TO BSC THAT AFTER BEING EXTUBATED AND DOING WELL FOR SEVERAL DAYS, THE PATIENT BEGAN HAVING DIFFICULTY BREATHING AND REQUIRED REINTUBATION. THE PATIENT¿S FAMILY THEN DECIDED TO TRANSITION TO PALLIATIVE CARE AND REQUESTED VENTILATION BE STOPPED. THE PATIENT DIED OF RESPIRATORY FAILURE ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904401 WATCHMAN® ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - GALWAY M635TU20060 20170676 08714729838203

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| R