BEUDAMED
    FDA Adverse Event Summary report: N

    AMPLATZER® SEPTAL OCCLUDER

    MDR report key: 2132045 · Received June 16, 2011

    Report

    Report Number
    2135147-2011-00075
    Date Received
    June 16, 2011
    Date of Event
    August 27, 2010
    Report Date
    June 17, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS CURRENTLY BEING INVESTIGATED FURTHER AND WILL BE REVIEWED BY AGA MEDICAL EROSION BOARD CHAIRS. THIS MDR WILL BE UPDATED IF A DEFINITE EROSION IS CONFIRMED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(4) STUDY, INDICATED THE (B)(6) FEMALE HAD A SECUNDUM ASD. THE AORTIC RIM WAS PRESENT, THE AV VALVE, SVC AND IVC RIMS WERE SUFFICIENT. BALLOON SIZING WAS PERFORMED WITH A 24MM AMPLATZER SIZING BALLOON TO STOP-FLOW DIAMETER OF 16MM. A 16MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED. POST-IMPLANT, A 1-2MM SHUNT WAS OBSERVED THROUGH THE ASO. ON (B)(6) 2010, DURING A ONE-MONTH FOLLOW-UP, THE PATIENT HAD A SMALL INFERIOR PERICARDIAL EFFUSION SLIGHTLY INCREASED FROM (B)(4), HEMODYNAMICALLY INSIGNIFICANT, RESOLVED AT FOLLOW-UP WITH LOCAL CARDIOLOGIST. NO TREATMENT WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER® SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-016

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR