BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 527912 · Received June 2, 2004

    Report

    Report Number
    2135147-2004-00031
    Event Type
    Death
    Date Received
    June 2, 2004
    Date of Event
    April 28, 2004
    Report Date
    June 1, 2004
    Manufacturer
    AGA MEDICAL CORP.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2004, PERCUTANEOUS CLOSURE WITH A 22MM ASD DEVICE WAS PERFORMED WITH NO COMPLICATIONS ON A PT WITH A 16MM DIAMETER SECUNDUM ATRIAL SEPTAL DEFECT WITH WELL DEVELOPED RIMS, NO FLOPPY SEPTUM, AND NO ACCESSORY HEART ANOMALIES. THE NEXT DAY, PROPER POSITION OF THE DEVICE WAS CONFIRMED BY CONTROL TTE WITH NO EFFUSION; BOTH ECG AND X-RAY WERE WITHIN NORMAL LIMITS. THE FOLLOWING DAY, HOLTER MONITOR READINGS WERE WITHIN NORMAL LIMITS. A DAY LATER, CONTROL TTE CONFIRMED DEVICE POSITION, NORMAL FLOWS, AND NO LEAKAGE OF PERICARDIAL FLUID. THE PT WAS ADMINISTERED ASPIRIN AND FRAXIPARINE AND DISCHARGED IN GOOD CLINICAL CONDITION WITH ORDERS TO TAKE ASPIRIN FOR 6 MONTHS, FOLLOW ENDOPROPHYLAXIS FOR 12 MONTHS, AND WITHHOLD PHYSICAL EFFORTS FOR 12 MONTHS. SIX DAYS LATER, THE CLINIC RECEIVED NOTIFICATION BY FAX OF THE PT'S SUDDEN DEATH. NO FURTHER INFO WAS RECEIVED BY THE CLINIC REGARDING THE CIRCUMSTANCES OF THE DEATH OR THE RESULTS OF THE POSTMORTEM EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORP. NA M03G18-26

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Death