BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER CRIBRIFORM OCCLUDER

    MDR report key: 3820089 · Received May 20, 2014

    Report

    Report Number
    2135147-2014-00043
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ALSO, THE DEVICE'S MANUFACTURING RECORDS COULD NOT BE REVIEWED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    A 25MM AMPLATZER CRIBRIFORM OCCLUDER (ACO) WAS IMPLANTED IN THE PATIENT'S PATENT FORAMEN OVALE (PFO); HOWEVER, TWO WEEKS LATER THE ACO DID NOT APPEAR TO BE SITTING PROPERLY IN THE DEFECT AND WAS EXPLANTED. THE PFO WAS SURGICALLY REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300353 AMPLATZER CRIBRIFORM OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-MF-025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention