BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 17873285 · Received October 4, 2023

    Report

    Report Number
    2135147-2023-04326
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 1, 1995
    Report Date
    October 4, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE ATTACHMENT: ARTICLE TITLE: LONG-TERM FOLLOW-UP OF PERCUTANEOUS SECUNDUM-TYPE ATRIAL SEPTAL DEFECT CLOSURE USING AMPLATZER SEPTAL OCCLUDER SINCE 1995: A SINGLE-CENTRE STUDY. THE ADDITIONAL PATIENT EFFECTS REPORTED IN THE ARTICLE ARE CAPTURED UNDER SEPARATE EMDR REPORT. SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF AMPLATZER SEPTAL OCCLUDER WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING ATRIAL SEPTAL DEFECT. SOME OF THE COMPLICATIONS REPORTED WERE DEVICE EMBOLIZATION, THROMBUS, EROSION, INFECTIVE ENDOCARDITIS, RESIDUAL SHUNT, ARRHYTHMIAS, PERICARDIAL EFFUSION, CARDIAC PERFORATION, SURGICAL INTERVENTION, HOSPITALIZATION, AND UNEXPECTED MEDICAL INTERVENTION; 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. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THE ARTICLE, ¿LONG-TERM FOLLOW-UP OF PERCUTANEOUS SECUNDUM-TYPE ATRIAL SEPTAL DEFECT CLOSURE USING AMPLATZER SEPTAL OCCLUDER SINCE 1995: A SINGLE-CENTRE STUDY¿, WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE SINGLE CENTER STUDY TO EVALUATE LONG-TERM RESULTS OF PERCUTANEOUS CLOSURE OF SECUNDUM-TYPE ATRIAL SEPTAL DEFECT USING AMPLATZER SEPTAL OCCLUDER WITH THE FOLLOW-UP TO 25 YEARS. DEVICE INCLUDED IN THIS STUDY WAS ONLY AMPLATZER SEPTAL OCCLUDER. THE ARTICLE CONCLUDED PERCUTANEOUS CLOSURE OF SECUNDUM-TYPE ATRIAL SEPTAL DEFECT USING AMPLATZER SEPTAL OCCLUDER IS A SAFE AND EFFECTIVE PROCEDURE ACCOUNTING FOR A VERY LOW INCIDENCE OF MAJOR COMPLICATIONS IN THE LONG-TERM FOLLOW-UP. [THE PRIMARY AND CORRESPONDING AUTHOR WAS PETER OLEJNIK, NATIONAL INSTITUTE OF CARDIOVASCULAR DISEASES, PEDIATRIC CARDIAC CENTER, BRATISLAVA, SLOVAKIA, WITH CORRESPONDING EMAIL: (B)(6).]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467411 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown