BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 14464885 · Received May 21, 2022

    Report

    Report Number
    2135147-2022-00306
    Event Type
    Injury
    Date Received
    May 21, 2022
    Report Date
    June 15, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, 214 PATIENTS UNDERWENT PERCUTANEOUS ASD CLOSURES BETWEEN OCTOBER 2014 AND FEBRUARY 2020; THE DEVICES ASSOCIATED WITH THIS STUDY WERE AMPLATZER SEPTAL OCCLUDER (ASO) AND FIGULLA FLEX II SEPTAL OCCLUDER (FSO). THERE WERE NO DIFFERENCES IN THE CLINICAL PERFORMANCE OF DEATH, EROSION, DROPOUT, STROKE, INFECTIVE ENDOCARDITIS, NEW-ONSET SUPRAVENTRICULAR TACHYARRHYTHMIA, NEW-ONSET MIGRAINE, AND RESIDUAL SHUNTING BETWEEN THE TWO GROUPS. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW, AND NO DEVICE OR ADDITIONAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.H6 MEDICAL DEVICE PROBLEM CODE 4001 REMOVED AND 2993 WAS ADDED.

    Description of Event or Problem · 0

    THE ARTICLE, "COMPARISON OF ANATOMICAL FEATURES AND POSTOPERATIVE CLINICAL RESULTS OF ASD BETWEEN TWO TYPES OF ASD CLOSURE DEVICES", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO ANALYZE THE POSTOPERATIVE CLINICAL RESULTS BETWEEN BOTH DEVICES AND THE ANATOMICAL FEATURES OF EACH ATRIAL SEPTAL DEFECT IN THE HOSPITAL. DEVICES INVOLVED INCLUDED AMPLATZER SEPTAL OCCLUDER (ASO) AND FIGULLA FLEX II SEPTAL OCCLUDER (FSO). THE ARTICLE CONCLUDED THAT ASOS WERE PLACED IN POSTERIOR RIM DEFECT CASES AND FSOS IN AORTIC-SUPERIOR RIM DEFECT, SEPTAL M MALALIGNMENT, AND EXTENSIVE RIM DEFECT CASES, BUT THERE WERE NO DIFFERENCES IN PATIENT CHARACTERISTICS OR TREATMENT EFFICACY AND SAFETY OUTCOMES BETWEEN THE TWO DEVICES. [THE AUTHOR OF THIS ARTICLE IS KOTARO MIURA, MD, DEPARTMENT OF CARDIOLOGY, KEIO UNIVERSITY HOSPITAL, 35 SHINANOMACHI, SHINJUKU-KU, TOKYO 160-8582].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582248 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Unknown Required Intervention