BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 19013989 · Received April 1, 2024

    Report

    Report Number
    2135147-2024-01428
    Event Type
    Death
    Date Received
    April 1, 2024
    Date of Event
    January 1, 2001
    Report Date
    April 24, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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. LITERATURE: ARTICLE TITLE: "IMPACT OF ATRIAL SEPTAL DEFECT CLOSURE ON MORTALITY IN OLDER PATIENTS".

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF IMPACT OF ATRIAL SEPTAL DEFECT CLOSURE ON MORTALITY IN OLDER PATIENTS WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, HYPERLIPIDEMIA, DIABETES MELLITUS, STROKE, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, HISTORY OF HEART FAILURE. SOME OF THE COMPLICATIONS REPORTED WAS DEATH THIS COMPLICATION IS 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. ¿LITERATURE ATTACHMENT: ARTICLE TITLE: IMPACT OF ATRIAL SEPTAL DEFECT CLOSURE ON MORTALITY IN OLDER PATIENTS.¿

    Description of Event or Problem · 0

    THE ARTICLE, "IMPACT OF ATRIAL SEPTAL DEFECT CLOSURE ON MORTALITY IN OLDER PATIENTS", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER TO EVALUATE THE MORTALITY RATES IN OLDER ATRIAL SEPTAL DEFECT (ASD) PATIENTS WITH AND WITHOUT CLOSURE. DEVICES INCLUDED IN THIS STUDY WERE COCOON AND AMPLATZER SEPTAL OCCLUDER DEVICES. THE ARTICLE CONCLUDED THAT ASD CLOSURE DEMONSTRATED FAVORABLE OUTCOMES IN OLDER PATIENTS. AGE, NYHA CLASS, BLOOD UREA NITROGEN (BUN), RIGHT VENTRICULAR SYSTOLIC PRESSURE (RVSP), AND ASD CLOSURE WERE IDENTIFIED AS INDEPENDENT FACTORS LINKED TO MORTALITY IN THIS POPULATION. [THE PRIMARY AND CORRESPONDING AUTHOR WAS NITHIMA RATANASIT, MAHIDOL UNIVERSITY, 999 PHUTTHAMONTHON SAI 4 RD, SALAYA, PHUTTHAMONTHON DISTRICT, NAKHON PATHOM 73170, THAILAND, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM 01 JANUARY 2001 TO 31 JANUARY 2017. A TOTAL OF 299 PATIENTS WHO RECEIVED ASD CLOSURE WERE INCLUDED, OF WHICH IT COULD NOT BE CONFIRMED HOW MANY RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 55.1 YEARS AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED HYPERTENSION, HYPERLIPIDEMIA, DIABETES MELLITUS, STROKE, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, HISTORY OF HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052212 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death