BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 6108904 · Received November 17, 2016

    Report

    Report Number
    2134265-2016-10319
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 24, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    UDI-DI
    08714729838258
    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: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-10320. IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. THE WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED IN THE LAA AND A 30MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS ADVANCED AND SUCCESSFULLY DEPLOYED. SHORTLY AFTER THE CONCLUSION OF THE PROCEDURE, APPROXIMATELY 10-15 MINUTES, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE WHICH LED TO THE DISCOVERY OF A PERICARDIAL EFFUSION. IMAGING WAS PERFORMED BEFORE AND DURING THE PROCEDURE TO CHECK FOR EFFUSIONS. PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE CLOSURE DEVICE MOVED DURING RELEASE FROM THE CORE WIRE, HOWEVER IT WAS STILL ATTACHED TO THE WIRE WHEN IT MOVED. THE MOVEMENT WAS VERY MINIMAL AND IT THE DEVICE MOVED BACK INTO ITS ORIGINAL POSITION ONCE FULLY RELEASED. THE ORIGINAL RELEASE CRITERIA WAS UNCHANGED. IT WAS ALSO NOTED THERE WAS NO REASON TO BELIEVE THIS HAD ANYTHING TO DO WITH THE PERICARDIAL EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760241 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WU30060 19470149 08714729838258

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention