BEUDAMED
    FDA Adverse Event Summary report: N

    AMPLATZER® SEPTAL OCCLUDER

    MDR report key: 2132047 · Received June 16, 2011

    Report

    Report Number
    2135147-2011-00077
    Date Received
    June 16, 2011
    Date of Event
    December 9, 2009
    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 SVC AND IVC RIMS WERE SUFFICIENT; HOWEVER, THE AV VALVE RIM WAS NOT SUFFICIENT. BALLOON SIZING WAS PERFORMED WITH AN 18MM AMPLATZER SIZING BALLOON TO STOP-FLOW DIAMETER OF 16MM. A 16MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED. POST-IMPLANT, NO SHUNT WAS OBSERVED THROUGH THE ASO. ON (B)(6) 2009, A TRIVIAL PERICARDIAL EFFUSION VISIBLE ONLY IN THE PARASTERNAL SHORT AXIS ONLY 2-3MM (MAY BE NORMAL). NO TREATMENT WAS PROVIDED.

    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