BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 5069009 · Received September 10, 2015

    Report

    Report Number
    2134265-2015-06110
    Event Type
    Death
    Date Received
    September 10, 2015
    Date of Event
    May 19, 2015
    Report Date
    August 14, 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).

    Additional Manufacturer Narrative · 1

    UPN, CATALOG/MODEL #, DEVICE LOT NUMBER, DEVICE EXPIRATION DATE, DEVICE MANUFACTURED DATE: UPDATED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND DEATH OCCURRED. IN (B)(6) 2015 THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE AND A WATCHMAN CLOSURE DEVICE WAS IMPLANTED. APPROXIMATELY 4 MONTHS LATER, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND EXPIRED.

    Description of Event or Problem · 1

    EWOLUTION POST MARKET REGISTRY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND DEATH OCCURRED. IN (B)(6) 2015 THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE AND A WATCHMAN CLOSURE DEVICE WAS IMPLANTED. APPROXIMATELY 4 MONTHS LATER, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598536 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WS33060 16994017

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death