BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 747214 · Received September 8, 2005

    Report

    Report Number
    MW1036577
    Event Type
    Death
    Date Received
    September 8, 2005
    Date of Event
    September 4, 2005
    Report Date
    September 8, 2005
    Manufacturer
    AGA MEDICAL
    Product Code
    MLV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A #26 AMPLATZER OCCLUDER WAS USED TO CLOSE AN ASD WITH STRETCHED DIAMETER OF 23MM. THERE WERE NO COMPLICATIONS AND PT WAS DISCHARGED APPROXIMATELY 5HRS LATER. TWO DAYS LATER, SHE CALLED WITH CHEST PAIN AND WENT TO EMERGENCY DEPARTMENT. A 2D ECHO AND SPIRAL CT SHOWED NO PATHOLOGY. SHE WAS ADMITTED FOR OBSERVATION AND DISCHARGED THE NEXT MORNING. AT 8PM THAT NIGHT, SHE WENT TO EMERGENCY DEPARTMENT WITH RECURRENT PAIN, ARRESTED. THE CORONER FOUND HEMOPERICARDIUM AND 5MM PERFORATION OF LEFT ATRIAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER TO CLOSE ATRIAL SEPTAL DEFECT MLV AGA MEDICAL 9-ASD-026 M03A16-15

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death