BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 15192429 · Received August 9, 2022

    Report

    Report Number
    2134265-2022-08122
    Event Type
    Injury
    Date Received
    August 9, 2022
    Date of Event
    December 1, 2021
    Report Date
    August 9, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT - ESTIMATED AND DOCUMENTED IN THIS REPORT AS (B)(6) 2021 AS THE ARTICLE WAS PUBLISHED IN DECEMBER 2021. (B)(6). LITERATURE CITATION: DELLA ROCCA DG, MURTAZA G, DI BIASE L, AKELLA K, KRISHNAN SC, MAGNOCAVALLO M, MOHANTY S, GIANNI C, TRIVEDI C, LAVALLE C, FORLEO GB, NATALE VN, TARANTINO N, ROMERO J, GOPINATHANNAIR R, PATEL PJ, BASSIOUNY M, DEL PRETE A, AL-AHMAD A, BURKHARDT JD, GALLINGHOUSE GJ, SANCHEZ JE, DOSHI SK, HORTON RP, LAKKIREDDY D, NATALE A. RADIOFREQUENCY ENERGY APPLICATIONS TARGETING SIGNIFICANT RESIDUAL LEAKS AFTER WATCHMAN IMPLANTATION: A PROSPECTIVE, MULTICENTER EXPERIENCE. JACC CLIN ELECTROPHYSIOL. 2021 DEC;7(12):1573-1584. DOI: 10.1016/J.JACEP.2021.06.002. EPUB 2021 JUL 27. PMID: 34330671.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT THE CLOSURE DEVICE DID NOT SEAL AND PERICARDIAL EFFUSION OCCURRED. FOLLOW UP ON LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURES WERE PERFORMED FOR 43 PATIENTS WITH SIGNIFICANT PERI-DEVICE LEAKS. THE AVERAGE SIZE OF THE LEAKS WAS 5MM (RANGE: 4 TO 7MM). THE AVERAGE AGE AT THE TIME OF FOLLOW UP WAS 75 YEARS. THE AVERAGE CHA2DS2-VASC SCORE WAS 4.6, AND THE AVERAGE HAS-BLED SCORE WAS 4.0. FORTY OF THE 43 PROCEDURES WERE PERFORMED CONCOMITANTLY WITH REPEAT LEFT ATRIAL ABLATION WITH THE PATIENTS ALL IN SINUS RHYTHM AT THE TIME THE RADIOFREQUENCY (RF)-BASED LEAK CLOSURE PROCEDURE WAS INITIATED. INCOMPLETE LEFT ATRIAL APPENDAGE (LAA) OCCLUSION WAS DOCUMENTED POST CLOSURE DEVICE DEPLOYMENT IN 19 PATIENTS. FOUR OF THESE 19 PATIENTS HAD WATCHMAN FLX CLOSURE DEVICES IMPLANTED. THE OTHER 24 OF THE 43 TOTAL PATIENTS IN THE STUDY HAD SIGNIFICANT RESIDUAL LEAKS DOCUMENTED AT THE TIME OF THE ROUTINE FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING OCCURRING AN AVERAGE 8.2 MONTHS POST INDEX PROCEDURE. OUT OF THESE 24 PATIENTS, ALL OF THEM HAD WATCHMAN 2.5 CLOSURE DEVICES IMPLANTED. RF-BASED LEAK CLOSURE WAS PERFORMED FOLLOWING CLOSURE DEVICE IMPLANTATION IN 19 PATIENTS AND FOLLOWING EVIDENCE OF SIGNIFICANT LEAKS ON FOLLOW UP TEE IN 24 OTHER PATIENTS. THERE WERE AN AVERAGE OF 18 RF APPLICATIONS PER PATIENT TARGETING THE ATRIAL EDGE OF THE LEAK. POST-RF MEDIAN LEAK SIZE WAS 0MM (RANGE: 0-1MM). ONLY ONE PERIPROCEDURAL COMPLICATION WAS OBSERVED. FOLLOW UP TEE REVEALED COMPLETE LAA SEALING IN 23 PATIENTS AND NEGLIGIBLE LEAKS IN 15 PATIENTS. ONE PATIENT DEVELOPED A SUBACUTE PERICARDIAL EFFUSION WITHOUT HEMODYNAMIC COMPROMISE DURING THE PROCEDURE. PERICARDIOCENTESIS WAS PERFORMED, AND 250ML OF SEROSANGUINOUS FLUID WAS DRAINED VIA OVERNIGHT PERICARDIAL DRAINAGE. THE PATIENT WAS DISCHARGED FOLLOWING OVERNIGHT OBSERVATION. TWO PATIENTS DURING THE STUDY HAD MINOR ACCESS SITE HEMATOMAS. THE PATIENTS WERE DISCHARGED FOLLOWING OVERNIGHT OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294781 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention