BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 11356678 · Received February 21, 2021

    Report

    Report Number
    2135147-2021-00064
    Event Type
    Injury
    Date Received
    February 21, 2021
    Date of Event
    January 2, 2021
    Report Date
    March 17, 2021
    Manufacturer
    ABBOTT MEDICAL
    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, BETWEEN APRIL 2013 AND APRIL 2019, 380 PATIENTS WITH A SECUNDUM ATRIAL SEPTAL DEFECT UNDERWENT TRANSCATHETER CLOSURE USING AN OCCLUTECH FIGULLA FLEX II (190) OR AN AMPLATZER SEPTAL OCCLUDER (190). EVENTS OF RESIDUAL SHUNT AND ATRIAL FIBRILLATION WERE REPORTED. 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,"EFFICACY AND SAFETY OF ATRIAL SEPTAL DEFECT CLOSURE USING OCCLUTECH FIGULLA FLEX II COMPARED WITH AMPLATZER SEPTAL OCCLUDER" WAS REVIEWED. THE RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EXAMINE THE EFFICACY AND SAFETY OF OCCLUTECH FIGULLA FLEX II (FFII) COMPARED WITH AMPLATZER SEPTAL OCCLUDER (ASO) FOR TRANSCATHETER ATRIAL SEPTAL DEFECT (ASD) CLOSURE. AMPLATZER SEPTAL OCCLUDER(ABBOTT) AND OCCLUTECH FIGULLA FLEX II(OCCLUTECH GMBH) WERE ASSOCIATED WITH THE STUDY. THERE IS NO ALLEGATION OF MALFUNCTION OF THE ABBOTT DEVICES. THE ARTICLE CONCLUDED THAT THERE WAS NO DIFFERENCE IN THE PREVALENCE OF PROCEDURAL COMPLICATIONS OR THE PRESENCE OF A RESIDUAL SHUNT BETWEEN THE FFII GROUP AND THE ASO GROUP.THE PRIMARY AUTHOR IS RIE NAKAYAMA, DEPARTMENT OF CARDIOVASCULAR MEDICINE, OKAYAMA UNIVERSITY GRADUATE SCHOOL OF MEDICINE, DENTISTRY AND PHARMACEUTICAL SCIENCE, 2-5-1 SHIKATA-CHO, KITA-KU, OKAYAMA 700-8558, JAPAN. THE CORRESPONDENCE AUTHOR IS YOICHI TAKAYA, DEPARTMENT OF CARDIOVASCULAR MEDICINE, OKAYAMA UNIVERSITY GRADUATE SCHOOL OF MEDICINE, DENTISTRY AND PHARMACEUTICAL SCIENCE, 2-5-1 SHIKATA-CHO, KITA-KU, OKAYAMA 700-8558, JAPAN WITH THE EMAIL [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253589 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention