BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 17999681 · Received October 24, 2023

    Report

    Report Number
    2135147-2023-04638
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    September 1, 2011
    Report Date
    October 24, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF MITRAL REGURGITATION OUTCOMES AFTER TRANSCATHETER ATRIAL SEPTAL DEFECT CLOSURE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, DYSLIPIDEMIA, DIABETES MELLITUS, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION. SOME OF THE COMPLICATIONS REPORTED WERE HEART FAILURE, HOSPITALIZATION, SUPRAVENTRICULAR ARRHYTHMIA, NEWLY PRESCRIBED DIURETICS (UNEXPECTED MEDICAL INTERVENTION), WORSENING MITRAL REGURGITATION THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. 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 ANALYSIS. LITERATURE ATTACHMENT: ARTICLE TITLE "MITRAL REGURGITATION OUTCOMES AFTER TRANSCATHETER ATRIAL SEPTAL DEFECT CLOSURE".

    Description of Event or Problem · 0

    THE ARTICLE, ¿MITRAL REGURGITATION OUTCOMES AFTER TRANSCATHETER ATRIAL SEPTAL DEFECT CLOSURE¿, WAS REVIEWED. THE ARTICLE PRESENTED RETROSPECTIVE, SINGLE CENTER STUDY TO ELUCIDATE MITRAL REGURGITATION (MR) OUTCOMES AND PREDICTORS OF WORSENING MR AFTER TRANSCATHETER ATRIAL SEPTAL DEFECT (ASD) CLOSURE. DEVICES INCLUDED IN THIS STUDY WERE AMPLATZER SEPTAL OCCLUDER (ABBOTT, ST. PAUL, MN, USA) AND OCCLUTECH FIGULLA FLEX II ASD OCCLUDER (OCCLUTECH GMBH, JENA, GERMANY). THE ARTICLE CONCLUDED THAT WORSENING MR AFTER TRANSCATHETER ASD CLOSURE MIGHT DEPEND ON MITRAL VALVE (MV) LEAFLET FINDINGS AND ANNULUS SIZE IN PATIENTS WITH LONG-STANDING PERSISTENT ATRIAL FIBRILLATION. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MICHIYO YAMANO, DEPARTMENT OF CARDIOVASCULAR MEDICINE, GRADUATE SCHOOL OF MEDICAL SCIENCE, KYOTO PREFECTURAL UNIVERSITY OF MEDICINE, KAJII-CHO 465, KAWARAMACHI-HIROKOJI, KAMIGYO-KU, KYOTO 602-8566, JAPAN, WITH CORRESPONDING EMAIL: [email protected]].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813747 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H