BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 11073255 · Received December 24, 2020

    Report

    Report Number
    2135147-2020-00554
    Event Type
    Injury
    Date Received
    December 24, 2020
    Report Date
    December 31, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, ONE PATIENT HAD AN AMPLATZER ASD OCCLUDER WITH EMBOLIZED AFTER DEPLOYMENT. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    THE ARTICLE, " APPROPRIATE DEVICE SELECTION FOR TRANSCATHETER ATRIAL SEPTAL DEFECT CLOSURE USING THREE-DIMENSIONAL TRANSESOPHAGEAL " WAS REVIEWED. THE RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO ASSESS THE USEFULNESS OF 3D-TEE FOR THE PREPROCEDURAL ANALYSIS OF ATRIAL SEPTAL DEFECT(ASD) MORPHOLOGY BASED ON THE RESULTS. AMPLATZER SEPTAL OCCLUDER (ABBOTT) AND OCCLUTECH FIGULLA FLEX II OCCLUDER (OCCLUTECH INTERNATIONAL AB) WERE ASSOCIATED WITH THE STUDY. THERE IS NO ALLEGATION OF MALFUNCTION OF THE ABBOTT DEVICE. THE ARTICLE CONCLUDED THAT THREE-DIMENSIONAL TEE IS USEFUL FOR COMPREHENSIVELY EVALUATING THE MORPHOLOGICAL CHARACTERISTICS OF AN ASD. THE AUTHOR OF THE ARTICLE IS HIROKI KITAKATA, DEPARTMENT OF CARDIOLOGY, KEIO UNIVERSITY SCHOOL OF MEDICINE, TOKYO, JAPAN. THE CORRESPONDING AUTHOR IS YUJI ITABASHI, DEPARTMENT OF LABORATORY MEDICINE, KEIO UNIVERSITY SCHOOL OF MEDICINE, SHINANOMACHI 35, SHINJUKU-KU, TOKYO 160-8582, JAPAN WITH THE EMAIL [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537815 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention