BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 802757 · Received January 5, 2007

    Report

    Report Number
    2135147-2007-00002
    Event Type
    Injury
    Date Received
    January 5, 2007
    Date of Event
    December 4, 2006
    Report Date
    January 5, 2007
    Manufacturer
    AGA MEDICAL CORP.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE BEING NOTIFIED OF THE EVENT, AGA MEDICAL HAS REQUESTED ADD'L INFO FROM THE PHYSICIAN ON 12/06/2006, 12/20/2006, AND 01/03/2006. AS OF THE FILING OF THIS REPORT, NO ADD'L INFO HAS BEEN RECEIVED BY AGA MEDICAL.

    Description of Event or Problem · 1

    THE PT HAD MULTIPLE FENESTRATED ATRIAL SEPTAL DEFECTS. THE PT WAS PREPPED AT BOTH THE FEMORAL AND JUGULAR ACCESS BECAUSE THE PHYSICIAN WASN'T CERTAIN AT HOW HE WAS GOING TO REACH ALL THREE OF THE PT'S DEFECTS. THE FIRST DEVICE WAS DEPLOYED AND IMPLANTED SUCCESSFULLY; THE SECOND DEVICE (26MM AMPLATZER SEPTAL OCCLUDER) WAS RELEASED AND FELL INTO THE LEFT ATRIUM. DEVICE WAS RETRIEVED WITH A SNARE AND REMOVED BY A 14F SHEATH THROUGH THE JUGULAR. THE THIRD DEVICE TO CLOSE THE INFERIOR DEFECT NEXT TO THE IVC WASN'T ATTEMPTED DUE TO POSSIBLE IVC OBSTRUCTION. THE PT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORP. 9-ASD-026 M05M29-20

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention