BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 7577613 · Received June 7, 2018

    Report

    Report Number
    2135147-2018-00065
    Event Type
    Injury
    Date Received
    June 7, 2018
    Date of Event
    May 10, 2018
    Report Date
    July 10, 2018
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MAE
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT THAT THE "RETENTION SKIRT ON THE AORTIC SIDE PROTRUDED UP INTO THE AORTIC ARCH AND THE DEVICE SEEMED UNSTABLE" WAS REPORTED. THE INVESTIGATION CONFIRMED THE DEVICE MET FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS WHEN ANALYZED AT ABBOTT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2018, AN 8 MM AMPLATZER VASCULAR PLUG II (LOT NUMBER: 6279092) WERE SELECTED FOR IMPLANT, BUT WAS NOT RELEASED BECAUSE IT DID NOT FIT THE DEFECT APPROPRIATELY. THE AVP2 WAS EXCHANGED FOR A 6 MM AMPLATZER DUCT OCCLUDER (LOT NUMBER: 950615). THE ADO WAS RELEASED WITH GOOD PLACEMENT, HOWEVER, THE AORTIC SKIRT PROTRUDED UP INTO THE AORTIC ARCH AND THE DEVICE SEEMED UNSTABLE. THE USER WAS CONCERNED WITH DEVICE INSTABILITY, AND THE DEVICE WAS SURGICALLY RETRIEVED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, AN 8MM AMPLATZER VASCULAR PLUG II (AVP2) (LOT NUMBER: 6279092) WAS SELECTED FOR IMPLANT, BUT WAS NOT RELEASED BECAUSE IT DID NOT FIT THE DEFECT APPROPRIATELY. THE AVP2 WAS EXCHANGED FOR A 10-8MM AMPLATZER DUCT OCCLUDER (ADO) (LOT NUMBER: 950615). THE ADO WAS RELEASED WITH GOOD PLACEMENT, HOWEVER, THE AORTIC SKIRT PROTRUDED UP INTO THE AORTIC ARCH AND THE DEVICE SEEMED UNSTABLE AND AT RISK FOR EMBOLIZATION. THE USER WAS CONCERNED WITH DEVICE INSTABILITY, AND THE DEVICE WAS SURGICALLY RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419555 AMPLATZER DUCT OCCLUDER CARDIAC OCCLUSION DEVICE MAE AGA MEDICAL CORPORATION 9-PDA-006 5950615

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R