BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 4884335 · Received July 1, 2015

    Report

    Report Number
    2134265-2015-04142
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    February 16, 2015
    Report Date
    June 5, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPN CORRECTED FROM UNK727 TO M635WS30060. PMA# OR 510K# CORRECTED FROM M110009 TO P130013 (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    IT WAS FURTHER REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE, A PARTIAL RECAPTURE WAS PERFORMED AS THE DEVICE WAS INITIALLY DEPLOYED TOO DISTAL. THE CLOSURE DEVICE WAS THEN PLACED DISTAL TO AND SPANNED THE ENTIRE LAA OSTIUM WITH A COMPLETE SEAL NOTED. MEDICATION WAS GIVEN OR THE REGIMEN WAS ADJUSTED AND A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND LAB TESTS WERE PERFORMED. THE EVENT WAS CONSIDERED RESOLVED IN (B)(6) 2015.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT THROMBUS ON THE DEVICE OCCURRED. THE PATIENT HAD A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE AND A WATCHMAN ® LAA CLOSURE DEVICE WAS IMPLANTED. IMAGING FOLLOW UP PERFORMED SIX WEEKS AFTER THE DEVICE WAS IMPLANTED REVEALED THROMBUS ON THE ATRIAL FACING SURFACE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425495 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WS30060 16629591

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other