BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 6508801 · Received April 20, 2017

    Report

    Report Number
    2134265-2017-03497
    Event Type
    Injury
    Date Received
    April 20, 2017
    Date of Event
    March 24, 2017
    Report Date
    March 26, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NGV
    UDI-DI
    08714729838234
    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: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE EMBOLIZATION OCCURRED. IN (B)(6) 2017, THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. THE PROCEDURE WAS PERFORMED LATE AFTERNOON, THE LEFT ATRIAL PRESSURE WAS 18 AND THE PATIENT WAS NOTED TO HAVE CHRONIC ATRIAL FIBRILLATION. A 24MM WATCHMAN ® LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. ALL RELEASE CRITERIA WERE MET; THE COMPRESSION RANGED FROM 12-19%. THE PATIENT RETURNED FOR A FOLLOW UP APPOINTMENT IN (B)(6) 2017, 29 DAYS POST IMPLANT. THE CLOSURE DEVICE WAS FOUND IN THE DESCENDING AORTA. THE PATIENT WAS ASYMPTOMATIC. THE CLOSURE DEVICE WAS SNARED OUT THE SAME DAY. THERE WERE NO COMPLICATIONS POST-OPERATIVELY AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289887 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - GALWAY M635WU24060 19884655 08714729838234

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention