BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 6091029 · Received November 9, 2016

    Report

    Report Number
    2134265-2016-10422
    Event Type
    Death
    Date Received
    November 9, 2016
    Date of Event
    September 15, 2016
    Report Date
    October 15, 2016
    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

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    DESCRIBE EVENT OR PROBLEM , PATIENT CODE: UPDATED CONCLUSION CODE CORRECTED FROM (B)(4). DEVICE EVALUATED BY MFR: BASED ON ADDITIONAL INFORMATION, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS CHANGED TO ¿UNDETERMINABLE¿, INDICATING A REVIEW OF ALL AVAILABLE INFORMATION FAILED TO CONFIRM A PROBABLE ROOT CAUSE. THERE WAS NO EVIDENCE OF ANY SPECIFICATION NON-CONFORMANCES RELATED TO THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    (B)(6) STUDY: IT WAS REPORTED THAT THE PATIENT EXPIRED. IN (B)(6) 2015 A 21 WATCHMAN (TM) LAA CLOSURE DEVICE & DELIVERY SYSTEM WAS SUCCESSFULLY IMPLANTED DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. THE CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE SEAL AND WAS PLACED DISTAL TO AND SPANNED THE ENTIRE LAA OSTIUM. IT WAS REPORTED THAT THE PATIENT EXPIRED IN (B)(6) 2016. THE CAUSE OF THE DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED WITH ACUTE KIDNEY FAILURE 2 DAYS PRIOR TO THEIR DEATH. THE USER PHYSICIAN INDICATED THE DEATH WAS ATTRIBUTABLE TO RIGHT HEART FAILURE. THERE WERE NO CLINICAL SIGNS OF PERICARDIAL TAMPONADE. CHEST X-RAYS WERE NOT AVAILABLE FOR REVIEW. THE USER PHYSICIAN CONCLUDED THERE WAS NO ASSOCIATION WITH THE IMPLANTED WATCHMAN DEVICE, AND NO EVIDENCE OF A SERIOUS DEVICE RELATED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739670 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WS21060 17522735

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death