BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER OCCLUDER (UNKNOWN)

    MDR report key: 12628856 · Received October 13, 2021

    Report

    Report Number
    2135147-2021-00401
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    August 25, 2021
    Report Date
    October 26, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, THE DEVICE DISLOCATED AFTER DELIVERY AND 2 PATIENTS HAD PERSISTING PULMONARY HYPERTENSION AFTER INTERVENTION. 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 · 0

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

    Description of Event or Problem · 0

    THE ARTICLE, "SECUNDUM TYPE ATRIAL SEPTAL DEFECT IN PATIENTS WITH TRISOMY21¿THERAPEUTIC STRATEGIES, OUTCOME, AND SURVIVAL: A NATIONWIDE STUDY OF THE GERMAN NATIONAL REGISTRY FOR CONGENITAL HEART DEFECTS", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTI CENTER EXPERIENCE TO ANALYZE THERAPY, MORBIDITY AND SURVIVAL OF PATIENTS, WITH TRISOMY 21 AND SECUNDUM TYPE ATRIAL SEPTAL DEFECT (ASD II) WITH A SPECIAL FOCUS ON THE PRESENCE OF (PRE-EXISTING OR PERSISTING) PULMONARY HYPERTENSION/PULMONARY VASCULAR DISEASE (PVD) AFTER THE INTERVENTION/SURGERY. AMPLATZER DEVICES, FIGULLA FLEX, STARFLEX, HELEX AND SOLYSAFE DEVICES WERE ASSOCIATED WITH THE STUDY. THE ARTICLE CONCLUDED THAT THE OUTCOME OF TRISOMY 21 PATIENTS WITH AN ASD II BUT WITHOUT PVD IS EXCELLENT. HOWEVER, PVD, EITHER PRECLUDING ASD-CLOSURE OR DEVELOPMENT OF PROGRESSIVE PVD AFTER ASD-CLOSURE, IS ASSOCIATED WITH SIGNIFICANT MORTALITY IN THIS COHORT. THE PRIMARY AND CORRESPONDENCE AUTHOR OF THE ARTICLE IS ASTRID E. LAMMERS, DEPARTMENT OF CARDIOLOGY III¿ADULT CONGENITAL AND VALVULAR HEART DISEASE, UNIVERSITY HOSPITAL MUENSTER, 48149 MÜNSTER, GERMANY WITH THE CORRESPONDING EMAIL: [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520745 AMPLATZER OCCLUDER (UNKNOWN) TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention