BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 15978952 · Received December 14, 2022

    Report

    Report Number
    2124215-2022-52661
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    December 1, 2022
    Report Date
    December 14, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT - ESTIMATED AS AWARE DATE SINCE UNKNOWN. WASS SY, GALO J, YOON S-H, ET AL. PREDICTORS OF SUCCESSFUL SAME-DAY DISCHARGE AND 1-YEAR OUTCOMES AFTER LEFT ATRIAL APPENDAGE CLOSURE. CATHETER CARDIOVASC INTERV. 2022;1-7. DOI:10.1002/CCD.30464.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT PERICARDIAL EFFUSION, STROKE AND DEVICE LEAK OCCURRED POST PROCEDURE. THIS STUDY EXPLORED PREDICTORS OF SUCCESSFUL SAME-DAY DISCHARGE (SDD) AND REPORTED 1-YEAR OUTCOMES IN PATIENTS WHO UNDERWENT LAAC WITH SDD AND RECEIVED A WATCHMAN FLX LAA CLOSURE DEVICE. A PROSPECTIVE ANALYSIS WAS PERFORMED OVER A 20-MONTH PERIOD OF 225 CONSECUTIVE PATIENTS THAT UNDERWENT LAAC IN A LARGE, ACADEMIC HOSPITAL. ALL PATIENTS INCLUDED IN THE STUDY UNDERWENT A SDD PROTOCOL. BASELINE CHARACTERISTICS AND 1-YEAR OUTCOMES OF PATIENTS DISCHARGED SAME DAY OF THE PROCEDURE VERSUS THOSE THAT REQUIRED AT LEAST ONE OVERNIGHT STAY WERE COMPARED. ADVERSE EVENTS, PROCEDURAL SUCCESS, AND PROCEDURE TIMES WERE EVALUATED. OF THE 225 PATIENTS, THE OVERALL POST PROCEDURE COMPLICATION RATE WAS 2.7%: THREE PATIENTS HAD PERICARDIAL EFFUSION THAT DID NOT REQUIRE DRAINAGE (1.3%), AND THREE PATIENTS DEVELOPED COMPLICATIONS FROM THEIR ACCESS SITE (1.3%; TWO HEMATOMAS; ONE PSEUDOANEURYSM). AT 1 YEAR, STROKE EVENTS WERE INFREQUENT, WITH ONE PATIENT IN THE SDD AND NONE IN THE NSDD GROUPS. ALSO, THERE WERE TWO PATIENTS WITH A GREATER THAN 5MM RESIDUAL LEAK NOTED AT THE 45 DAY FOLLOW UP; ONE PATIENT FROM EACH GROUP. AT 1 YEAR, THERE WERE NO SIGNIFICANT DIFFERENCES IN STROKE OR DEATH RATES. SDD LAAC APPEARS TO BE SAFE AND EFFECTIVE IN BOTH THE SHORT-TERM AND MID-TERM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1981231 WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other