BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 15941114 · Received December 8, 2022

    Report

    Report Number
    2124215-2022-51030
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    November 21, 2022
    Report Date
    December 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: ESTIMATED SINCE UNKNOWN. JOURNAL ARTICLE: CHARATE, R. ET AL. "EVALUATION OF MULTIMODALITY LAA LEAK CLOSURE METHODS FOLLOWING INCOMPLETE OCCLUSION" JACC: CARDIOVASCULAR INTERVENTIONS: VOL. 15, NO 21, 2022. P. 2158-2170.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT DEVICE DID NOT SEAL. 160 PATIENTS (MEAN AGE 72 YEARS PLUS OR MINUS 9 YEARS; 71% MEN) UNDERWENT 1 OF THE 3 AVAILABLE MODALITIES (DETACHABLE EMBOLIZATION COILS, VASCULAR PLUGS OR SEPTAL OCCLUDERS, AND RADIOFREQUENCY ABLATION) FOR RESIDUAL CENTRAL OR ECCENTRIC LEAK CLOSURE. BOTH ACUTE POSTPROCEDURAL SUCCESS (CLOSURE OR LESS THAN 1-MM LEAK AT THE END OF THE PROCEDURE) AND CLOSURE AT 1-YEAR FOLLOW-UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY IMAGING WERE EVALUATED. OF 160 PATIENTS, 0.6%, 41.3%, AND 58.1% HAD MILD (1-2 MM), MODERATE (3-5 MM), AND SEVERE (GREATER THAN 5 MM) LEAKS, RESPECTIVELY. BASELINE LEFT ATRIAL APPENDAGE (LAA) CLOSURE TYPE WAS 72.5% WATCHMAN FLX. SUCCESSFUL CLOSURE (0- OR LESS THAN 1-MM LEAK) WAS SEEN IN 100% OF PATIENTS IN ALL COHORTS FOLLOWING INTERVENTION, WITH OVERALL COMPLETE CLOSURE (0-1 MM) OR MILD OR MINIMAL LEAKS (1-2 MM) ON 1-YEAR FOLLOW-UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY SEEN IN 100% OF THE ATRIAL SEPTAL OCCLUDER OR VASCULAR PLUG COHORT, 85.9% OF THE COIL COHORT, AND 83.3% OF THE RADIOFREQUENCY ABLATION COHORT (P < 0.001). TWO PATIENTS (1.3%) EXPERIENCED CARDIAC TAMPONADE, AND THERE WERE NO DEATHS OR OTHER COMPLICATIONS. A TOTAL OF 160 PATIENTS WITH CRICS FOLLOWING LAA CLOSURE WERE REFERRED FOR LAA LEAK CLOSURE. COHORT CONSISTED OF THE FOLLOWING PRIMARY LAA CLOSURE TECHNIQUES: WATCHMAN (69.3% [N = 111]), WATCHMAN FLX (3.1% [N = 5]). COMORBIDITIES AND ANTICOAGULATION OR ANTIPLATELET CHARACTERISTICS ALONG WITH FURTHER BASELINE CHARACTERISTICS ARE LISTED IN TABLE 1. LEAK SIZES IN THE STUDY COHORT WERE AS FOLLOWS: 2 MM (0.6%), 3 MM (10%), 4 MM (31.3%), 5 MM (48.8%), 6 MM (6.8%), 7 MM (1.8%), AND 8 MM (0.6%). TIME FROM DEVICE IMPLANTATION TO LAA LEAK CLOSURE. CLOSURE WAS PERFORMED WITH DETACHABLE EMBOLIZATION COILS (40% [N = 64]), ASOS OR VPS (22.5% [N = 36]), AND RFA (37.5% [N = 60]). OUR STUDY CONSISTED OF PATIENTS WHO, AFTER LAA CLOSURE BUT PRIOR TO LEAK CLOSURE, EXPERIENCED TRANSIENT ISCHEMIC ATTACKS (TIA) (14.1%), CARDIOVASCULAR ACCIDENT (CVA) (8.3%), CLINICAL THROMBOEMBOLISM (10.0%), MAJOR BLEEDING EVENTS (31.3% VS 36.1% VS 48.3%), AND MINOR BLEEDING EVENTS (16.1% VS 13.9% VS 33.3%) IN THE COIL, PLUG, AND RADIOFREQUENCY ABLATION LEAK CLOSURE COHORTS, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260055 WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention