BEUDAMED
    FDA Adverse Event Summary report: N

    AMPLATZER VASCULAR PLUG II

    MDR report key: 1842129 · Received September 23, 2010

    Report

    Report Number
    2135147-2010-00147
    Date Received
    September 23, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 28, 2010
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    KRD
    PMA / PMN Number
    K071699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, WHILE ADVANCING THE 10MM AMPLATZER VASCULAR PLUG II (AVPII) THROUGH THE SHEATH, THE DEVICE DETACHED. IT WAS ATTEMPTED TO BE REATTACHED TO THE SCREW WHILE THE AVPII WAS IN THE SHEATH AND WAS NOT SUCCESSFUL. THE DEVICE WAS NOT ABLE TO BE REMOVED FROM THE SHEATH AND THE SHEATH WAS CUT OFF WITH THE DEVICE INSIDE SO A REPLACEMENT AVPII COULD BE DEPLOYED. THIS EVENT IS BEING REPORTED SINCE THE DEVICE DETACHED FROM THE DELIVERY CABLE WITHIN THE DELIVERY SYSTEM AND HAD THE POTENTIAL TO EMBOLIZE INSIDE THE PATIENT. HOWEVER, NO ADVERSE EVENT OCCURRED AND NO FURTHER INTERVENTION WAS REQUIRED TO RETRIEVE THE AVPII. THE DEVICE HAS BEEN RECEIVED AT AGA MEDICAL AND IS CURRENTLY IN ANALYSIS. ONCE THE ANALYSIS IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER VASCULAR PLUG II ARTERIAL EMBOLIZATION DEVICE KRD AGA MEDICAL CORPORATION 9-AVP2-010 1007124794

    Patients

    Seq Age Sex Outcome Treatment
    1