BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 6154202 · Received December 8, 2016

    Report

    Report Number
    2134265-2016-11154
    Event Type
    Death
    Date Received
    December 8, 2016
    Date of Event
    October 29, 2016
    Report Date
    November 11, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    UDI-DI
    08714729838241
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: 2134265-2016-11779. IT WAS REPORTED A PERICARDIAL EFFUSION WITH TAMPONADE OCCURRED AND THE PATIENT DIED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A 27MM WATCHMAN ® LAA CLOSURE DEVICE AND DELIVERY SYSTEM WAS USED ALONG WITH A WATCHMAN ® ACCESS SYSTEM. THERE WAS NO PERICARDIAL EFFUSION NOTED AT THE BEGINNING OF THE CASE AND NO PERICARDIAL EFFUSION AFTER COMPLETION OF THE PROCEDURE. THE CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS GIVEN A DOSE OF WARFARIN LATER THAT NIGHT. THE NEXT DAY, THE PATIENT WAS HYPOTENSIVE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED A MODERATE PERICARDIAL EFFUSION, BUT THERE WAS NO TAMPONADE. THEY DID NOT DRAIN THE FLUID AT THAT TIME. THE BASELINE CREATININE WAS 1.6 AND THEN INCREASED TO 4.8, 70 CC OF DYE WAS USED. THE INTERNATIONAL NORMALIZED RATIO (INR) ALSO INCREASED TO 6.7. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR SIGNS OF HEART FAILURE. 10 DAYS AFTER THE INITIAL PERICARDIAL EFFUSION, A PERICARDIOCENTESIS WAS PERFORMED DUE TO TAMPONADE. THE PATIENT HAD A PROLONGED HOSPITALIZATION AND EXPIRED ABOUT A MONTH AFTER THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805620 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WU27060 18085143 08714729838241

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| R