BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 6199750 · Received December 22, 2016

    Report

    Report Number
    2134265-2016-12296
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    December 8, 2016
    Report Date
    December 8, 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
    FL, 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).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-12297 & 2134265-2016-12298. IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND A BASELINE PERICARDIAL EFFUSION WAS OBSERVED. DURING THE PROCEDURE, TWO WATCHMAN® ACCESS SYSTEMS WERE UTILIZED AND A 30MM WATCHMAN ® LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED IN THE LAA. THE PATIENT WAS TRANSFERRED TO RECOVERY. APPROXIMATELY 45 MINUTES TO 1 HOUR POST PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION AND BRADYCARDIA. ANOTHER TEE WAS PERFORMED; THE DEVICE REMAINED SECURE IN THE LAA AND THE PERICARDIAL EFFUSION DID NOT APPEAR TO HAVE CHANGED. HOWEVER, THE PHYSICIAN PROCEEDED TO TREAT THE PATIENT WITH PERICARDIOCENTESIS AND ABOUT 400 CC¿S OF BLOOD WAS WITHDRAWN AND THE PATIENT STABILIZED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848351 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WU30060 19653518 08714729838258

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention