BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 791504 · Received December 4, 2006

    Report

    Report Number
    2135147-2006-00077
    Event Type
    Other
    Date Received
    December 4, 2006
    Date of Event
    October 30, 2006
    Report Date
    December 4, 2006
    Manufacturer
    AGA MEDICAL CORP.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE BEING NOTIFIED OF THE EVENT, AGA MEDICAL HAS REQUESTED ADDITIONAL INFORMATION FROM THE PHYSICIAN ON 11/2/2006, 11/20/2006, AND 11/30/2006. AS OF THE FILING OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED BY AGA MEDICAL.

    Description of Event or Problem · 1

    ASO IMPLANTED TWO MONTHS AGO IN INFANT WITH CHRONIC LUNG DISEASE, VENTILATOR DEPENDENT. THE DEVICE WAS IMPLANTED BECAUSE RISK OF DEVICE CLOSURE WAS LESS RISK THAN SURGERY. TRACHEOSTOMY PERFORMED TWO WEEKS POST DEVICE IMPLANT. AN ELECTIVE BRONCHOSCOPY WAS PERFORMED AND COMPLICATED BY BRADYCARDIA, CARDIAC COMPRESSIONS WERE THEN INITIATED. AN ENLARGING PERICARDIAL EFFUSION WAS NOTED ON ECHO AND THE POSSIBILITY OF PERFORATION RAISED. THE EFFUSION IS DECREASING IN SIZE, AND THE DEVICE REMAINS IN PLACE WITH NO RESIDUAL LEAK. NO CHANGE IN CLINICAL STATUS WITH EFFUSION. NO TREATMENT INITIATED. THE EFFUSION HAS RESOLVED ON THE LAST ECHO PERFORMED. THE PHYSICIAN BELIEVES THE EFFUSION WAS NOT RELATED TO EROSION, BUT TO CPR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORP. 9-ASD-008 M06A30-26

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Other