BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2972380 · Received February 21, 2013

    Report

    Report Number
    2135147-2013-00019
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 9, 2013
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REVIEWED BY THE ST. JUDE MEDICAL EROSION BOARD AND CONFIRMED THAT NO EROSION OCCURRED.

    Additional Manufacturer Narrative · 1

    ST. JUDE MEDICAL COULD NOT EVALUATE THE ASO INVOLVED IN THIS INCIDENT SINCE THE DEVICE REMAINS IMPLANTED. DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS.

    Description of Event or Problem · 1

    A 32MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED IN A PATIENT ON (B)(6) 2013. THE FOLLOWING DAY, A VERY SMALL PERICARDIAL EFFUSION WAS OBSERVED BUT IT STOPPED SUBSEQUENTLY. NO SERIOUS COMPLICATIONS SUCH AS EROSION WAS SUSPECTED. THE PATIENT PRESENTED WITH NO SYMPTOMS AND WILL BE KEPT UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75823 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-032 1111023470

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization