BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 4202698 · Received October 27, 2014

    Report

    Report Number
    2135147-2014-00102
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MAE
    PMA / PMN Number
    PP020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 5/4MM ADO WAS RETURNED TO SJM AND DECONTAMINATED. THE ADO WAS GROSSLY AND MICROSCOPICALLY EXAMINED, AND NO ANOMALIES WERE FOUND. THE ADO MET DIMENSIONAL SPECIFICATIONS WHEN MEASURED WITH A CALIPER. THE OCCLUDER WAS LOADED INTO A TEST 6F LOADER, DEPLOYED AND RETRACTED WITHOUT DIFFICULTY OR DEFORMATION, UNDER NON-PHYSIOLOGICAL CONDITIONS. THE DEVICE HISTORY RECORD FOR THIS PRODUCT WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. THE RESULTS OF THIS INVESTIGATION CONFIRMED THE ADO MET ALL FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS WHEN ANALYZED AT SJM. THERE WAS NO EVIDENCE TO SUGGEST THERE WAS AN INTRINSIC DEFECT IN THE OCCLUDER, AND THE CAUSE FOR THE EMBOLIZATION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    A 5/4MM AMPLATZER DUCT OCCLUDER (ADO) WAS IMPLANTED, APPEARED TO BE MIS-SIZED AND BECAME DISLODGED IN THE HEART. THE ADO WAS SUCCESSFULLY SNARED AND REMOVED WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684350 AMPLATZER DUCT OCCLUDER CARDIAC OCCLUSION DEVICE MAE AGA MEDICAL CORPORATION 9-PDA-003 4404718

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Required Intervention