BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER OCCLUDER (UNKNOWN)

    MDR report key: 11961607 · Received June 8, 2021

    Report

    Report Number
    2135147-2021-00229
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    April 21, 2021
    Report Date
    June 23, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    S REPORTED IN A RESEARCH ARTICLE, COMPLICATIONS FROM SEPTAL DEFECT CLOSURE INCLUDED DEVICE EMBOLIZATION, MITRAL VALVE COMPRESSION, ATRIOVENTRICULAR BLOCK, RIGHT VENTRICULAR FAILURE, PARTIAL ANOMALOUS PULMONARY VENOUS RETURN, MITRAL REGURGITATION, RESIDUAL SHUNT, AND DEVICE EXPLANT. 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. PLEASE NOTE, PER THE INSTRUCTIONS FOR USE FOR AN AMPLATZER PFO OCCLUDER,ARTMT100092310 REVISION A "THE AMPLATZER¿ PFO OCCLUDER IS A PERCUTANEOUS, TRANSCATHETER OCCLUSION DEVICE INTENDED TO CLOSE ALL TYPES OF PFOS (I.E. CLASSICAL AS WELL AS THOSE WITH ANEURYSM OF THE SEPTUM) IN PATIENTS WITH A HISTORY OF STROKE OR TRANSIENT ISCHEMIC ATTACKS (TIAS) DIAGNOSED BY ECHOCARDIOGRAPHY WITH RIGHT-TO-LEFT SHUNTING DURING THE VALSALVA MANEUVER"

    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, "PROCEDURAL PREDICTORS AND OUTCOMES OF PERCUTANEOUS SECUNDUM ATRIAL SEPTAL DEFECT CLOSURE IN CHILDREN AGED <6 YEARS", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EVALUATE THE FEASIBILITY AND SAFETY OF PERCUTANEOUS ATRIAL SEPTAL DEFECT(ASD) CLOSURE IN CHILDREN AGED <6 YEARS AND IDENTIFY PREDICTORS FOR PROCEDURAL FAILURE AND CHALLENGING CASES. AMPLATZER SEPTAL OCCLUDER, AMPLATZER CRIBRIFORM SEPTAL OCCLUDER AND AMPLATZER PFO OCCLUDER (ABBOTT MEDICAL), COCOON SEPTAL OCCLUDER (VASCULAR INNOVATIONS CO.), OCCLUTECH FIGULLA FLEX II (OCCLUTECH INTERNATIONAL AB), AND GORE CARDIOFORM SEPTAL OCCLUDER (WL GORE & ASSOCIATES) WERE ASSOCIATED WITH THE STUDY. THE ARTICLE CONCLUDED THAT PERCUTANEOUS ASD CLOSURE IN CHILDREN AGED <6 YEARS IS FEASIBLE AND SAFE AND SHOULD BE CONSIDERED IN YOUNG CHILDREN WITH ASD AND CONFIRMED LARGE LEFT-TO-RIGHT SHUNT. THE PRIMARY AUTHOR OF THE ARTICLE IS SEUL GI CHA, MD, DIVISION OF PEDIATRIC CARDIOLOGY, ASAN MEDICAL CENTER, UNIVERSITY OF ULSAN COLLEGE OF MEDICINE, SEOUL, KOREA. THE CORRESPONDING AUTHOR OF THE ARTICLE IS YOUNG-HWUE KIM, MD, PHD, DIVISION OF PEDIATRIC CARDIOLOGY, ASAN MEDICAL CENTER, UNIVERSITY OF ULSAN COLLEGE OF MEDICINE, 88, OLYMPIC-RO, SONGPA-GU, SEOUL 05505, KOREA WITH THE CORRESPONDING EMAIL: [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852301 AMPLATZER OCCLUDER (UNKNOWN) TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R