BEUDAMED
    FDA Adverse Event Summary report: N

    AMPLATZER® SEPTAL OCCLUDER

    MDR report key: 2132016 · Received June 16, 2011

    Report

    Report Number
    2135147-2011-00079
    Date Received
    June 16, 2011
    Date of Event
    November 5, 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 AV VALVE, SVC AND IVC RIMS WERE SUFFICIENT; HOWEVER, THE RETRO-AORTIC RIM WAS NOT SUFFICIENT. BALLOON SIZING WAS PERFORMED WITH AN PTS SIZING BALLOON TO STOP-FLOW DIAMETER OF 28MM. A 30MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED. POST-IMPLANT, NO SHUNT WAS OBSERVED THROUGH THE ASO. DISCHARGE ECHO SHOWED TRIVIAL PERICARDIAL EFFUSION. EFFUSION WAS FAINTLY SEEN ON PROCEDURAL ECHO. 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-030 M09B25-19

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR