BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 16989627 · Received May 23, 2023

    Report

    Report Number
    2135147-2023-02280
    Event Type
    Injury
    Date Received
    May 23, 2023
    Date of Event
    December 1, 2008
    Report Date
    May 23, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT 537 PATIENTS HAD UNDERGONE LAAC BETWEEN DECEMBER 2008 TO APRIL 2019. OUT OF 537, 112 PATIENTS WITH DEVICE RELATED THROMBUS AND 425 WITHOUT DEVICE RELATED THROMBUS. SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF AMPLATZER AMULET WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES, PAROXYSMAL AF, NON-PAROXYSMAL AF, ARTERIAL HYPERTENSION, STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA) PRIOR TO LAAC, AND DIABETES MELLITUS. SOME OF THE COMPLICATIONS REPORTED WERE DEVICE RELATED THROMBUS, ATRIAL FIBRILLATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW, AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSISNA

    Description of Event or Problem · 0

    THE ARTICLE, ¿CLINICAL AND ECHOCARDIOGRAPHIC RISK FACTORS FOR DEVICE-RELATED THROMBUS AFTER LEFT ATRIAL APPENDAGE CLOSURE: AN ANALYSIS FROM THE MULTICENTER EUROC-DRT REGISTRY¿, WAS REVIEWED. THIS RESEARCH ARTICLE IS AIMED TO INVESTIGATE RISK FACTORS FOR DEVICE-RELATED THROMBUS (DRT) AFTER LEFT ATRIAL APPENDAGE CLOSURE (LAAC) FROM CENTERS REPORTING TO THE EUROC-DRT REGISTRY. THE ARTICLE CONCLUDED THAT PATIENTS WITH DRT SHOWED HIGHER RATES OF PREVIOUS STROKE/TRANSIENT ISCHEMIC ATTACK (TIA) (49.1% VS. 34.7%, P<0.01), SPONTANEOUS ECHOCARDIOGRAPHIC CONTRAST (SEC) (44.9% VS. 27.7%, P<0.01) AND LOWER LEFT ATRIAL APPENDAGE (LAA) PEAK. DRT AFTER LAAC IS ASSOCIATED WITH ADVERSE OUTCOME AND APPEARS TO BE OF MULTIFACTORIAL ORIGIN, DEPENDING ON PATIENT CHARACTERISTICS, ANTICOAGULATION REGIMEN AND DEVICE POSITION. [THE PRIMARY AUTHOR OF THE ARTICLE IS VIVIAN VIJ1, DEPARTMENT OF CARDIOLOGY, UNIVERSITY HOSPITAL BONN, VENUSBERG-CAMPUS 1, 53127 BONN, GERMANY; KERSTIN PIAYDA, CARDIOVASCULÄRES CENTRUM, FRANKFURT, GERMANY; THE CORRESPONDENCE AUTHOR IS ALEXANDER SEDAGHAT, DEPARTMENT OF CARDIOLOGY, UNIVERSITY HOSPITAL BONN, VENUSBERG-CAMPUS 1, 53127 BONN, GERMANY, E-MAIL: [email protected]]. THE ANALYSIS INCLUDED 537 PATIENTS (112 WITH DRT AND 425 WITHOUT DRT) WHO HAD UNDERGONE LAAC BETWEEN 12/2008 AND 04/2019. THE AVERAGE AGE WAS 75 YEARS OLD WITH THE MAJORITY BEING MALE PATIENTS. COMORBIDITIES INCLUDE PAROXYSMAL AF, NON-PAROXYSMAL AF, ARTERIAL HYPERTENSION, STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA) PRIOR TO LAAC, AND DIABETES MELLITUS. DEVICES USED: THE AMPLATZER ACP AND AMULET (ABBOTT LABORATORIES, CHICAGO, IL, USA), LAMBRE (LIFETECH SCIENTIFC, SHENZHEN, CHINA) AND ULTRASEAL (CARDIA INC, EAGAN, MN, USA), WATCHMAN (BOSTON SCIENTIFC INC, MARLBOROUGH, MA, USA), WAVECREST (BIOSENSE WEBSTER INC, IRVINE, CA, USA) AND OCCLUTECH LAA OCCLUDER (OCCLUTECH INTERNATIONAL AB; HELSINGBORG, SWEDEN). PERI/POST COMPLICATIONS : DEVICE RELATED THROMBUS, ATRIAL FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541662 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Disability