BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1062528 · Received June 20, 2008

    Report

    Report Number
    2135147-2008-00047
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    December 26, 2006
    Report Date
    June 20, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM AN ARTICLE PUBLISHED IN CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS; TRANSCATHETER CLOSURE OF SECUNDUM ATRIAL DEFECT IN SMALL CHILDREN: BETWEEN 2000 AND 2004, 278 CHILDREN UNDERWENT PERCUTANEOUS ATRIAL SEPTAL DEFECT (ASD) CLOSURE IN BELGIUM. THE FOLLOWING MAJOR COMPLICATIONS WERE EXPERIENCED: TRANSIENT AV BLOCK WITH A 20MM AMPLATZER SEPTAL OCCLUDER IN A PATIENT (MFR REPORT # 2135147-2008-00047). PERICARDIAL EFFUSION WITH AN 18MM AMPLATZER SEPTAL OCCLUDER IN A PATIENT (MFR REPORT #2 135147-2008-00048).DEVICE EMBOLIZATION OCCURRED IN TWO PATIENTS. ONE WITH A 20MM AMPLATZER SEPTAL OCCLUDER IN A PATIENT. THE DEVICE WAS PERCUTANEOUSLY RETRIEVED WITH A 13F SHEATH (PREVIOUSLY REPORTED AS MFR REPORT # 2135147-2003-00017). THE OTHER WAS WITH AN 18MM AMPLATZER SEPTAL OCCLUDER IN A PATIENT (PREVIOUSLY REPORTED AS MFR REPORT # 2135147-2006-00037). AGA MEDICAL CONTACTED THE AUTHOR OF THIS ARTICLE AND NO ADDITIONAL INFORMATION WILL BE PROVIDED REGARDING THESE EVENTS. THE ARTICLE IS ATTACHED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-020 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 36 MO Required Intervention