BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 6976363 · Received October 25, 2017

    Report

    Report Number
    2135147-2017-00138
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    June 28, 2017
    Report Date
    June 20, 2018
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P120021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF A DEFORMED 25 MM AMPLATZER PFO OCCLUDER (PFO) WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A 25 MM AMPLATZER PFO OCCLUDER (PFO) WAS IMPLANTED. ON AN UNKNOWN DATE, THE PFO WAIST WAS FOUND TO HAVE DEFORMED AND PROTRUDED THROUGH THE DEVICE MESH DAMAGING THE CARDIAC TISSUE. ON (B)(6) 2017, THE PFO WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756590 AMPLATZER PFO OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-PFO-025 5239484

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention