BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 20440785 · Received October 14, 2024

    Report

    Report Number
    2124215-2024-62241
    Event Type
    Injury
    Date Received
    October 14, 2024
    Date of Event
    July 23, 2024
    Report Date
    October 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED AS (B)(6) 2024 AS THE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS (B)(6)2024. CITATION: ZOU Q, JIANG C, LIN P, YU Y, LI J, ZHAO F, HU H AND SUN S (2024) MANAGEMENT OF COMPLICATIONS ASSOCIATED WITH PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE WITH OR WITHOUT ABLATION: EXPERIENCE FROM 512 CASES OVER A 4 YEAR PERIOD. FRONT. CARDIOVASC. MED. 11:1388024. DOI: 0.3389/FCVM.2024.1388024.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT THE DEVICE DID NOT SEAL. A 64-YEAR-OLD MALE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WITH ABLATION PROCEDURE AFTER PREOPERATIVE ASSESSMENT. DURING THE PROCEDURE, A DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) OF THE LAA IDENTIFIED A CHICKEN WING MORPHOLOGY WITH AN OPENING DIAMETER OF 17MM AND A DEPTH OF 21MM. A 21MM WATCHMAN DEVICE WAS PRECISELY PLACED IN THE LAA, WITH NO RESIDUAL LEAKS DETECTED, AND THE COMPRESSION RATIO RANGED FROM 15% TO 20%, ENSURING THE DEVICE WAS APPROPRIATELY SECURE. POST DISCHARGE, THE PATIENT WAS PUT ON A 12-WEEK MEDICATION REGIMEN OF RIVAROXABAN (20 MG DAILY) AND ASPIRIN (100 MG DAILY) FOR ANTICOAGULATION AND ANTIPLATELET THERAPY. ON THE 50TH DAY AFTER THE PROCEDURE, DURING A ROUTINE FOLLOW-UP, NO ISCHEMIC STROKE, TRANS ISCHEMIC ATTACK, OR BLEEDING COMPLICATIONS WERE REPORTED. HOWEVER, A CARDIAC CT ANGIOGRAPHY (CCTA) SCAN REVEALED A 5MM PERI-DEVICE LEAK (PDL) AT THE LOWER EDGE OF THE DEVICE. AFTER RULING OUT ISSUES RELATED TO DEVICE SIZE AND COMPRESSION RATIO DURING THE PROCEDURE, IT WAS SPECULATED THAT THE PDL MIGHT BE DUE TO INCOMPLETE ENDOTHELIALIZATION AROUND THE DEVICE. THE PATIENT WAS ADVISED TO CONTINUE WITH RIVAROXABAN AND ASPIRIN AND UNDERGO REGULAR FOLLOW-UPS. A CCTA RE-EXAMINATION 2 MONTHS LATER SHOWED THAT THE PDL HAD REDUCED TO 1.6 MM, AND NO ADVERSE EVENTS WERE REPORTED IN SUBSEQUENT FOLLOW-UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208469 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10365

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other