BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 541091 · Received August 11, 2004

    Report

    Report Number
    541091
    Event Type
    Other
    Date Received
    August 11, 2004
    Date of Event
    August 3, 2004
    Report Date
    August 11, 2004
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED TO CLOSE A SECUNDUM TYPE ASD, ATRIAL SEPTAL DEFECT. PROCEDURE WAS SUCCESSFUL WITHOUT COMPLICATION. THE FOLLOWING DAY THE OCCLUDER WAS NOTED TO HAVE EMBOLIZED TO THE RIGHT VENTRICULAR OUTFLOW TRACT. THE PATIENT WAS TAKEN TO SURGERY WHERE THE DEVICE WAS REMOVED AND THE ASD CLOSED. THE SURGEON NOTED THE DEVICE TO BE CAUGHT WITHIN THE PAPILLARY MUSCLES. THE PATIENT DID WELL AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-032 M04B06-30

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR NO OTHER THERAPIES