BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMPLAZTER VASCULAR PLUG

    MDR report key: 644304 · Received November 1, 2005

    Report

    Report Number
    2135147-2005-00051
    Event Type
    Other
    Date Received
    November 1, 2005
    Date of Event
    October 1, 2005
    Report Date
    November 1, 2005
    Manufacturer
    AGA MEDICAL CORP.
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN INTERVENTIONAL RADIOLOGIST STATED THAT HE USED AN AMPLATZER VASCULAR PLUG TO CLOSE OFF THE INTERNAL ILIAC PRIOR TO STENT GRAPH PROCEDURE AND THE PT ENDED UP WITH A VERY SERIOUS INFECTION. THE RADIOLOGIST DIDN'T KNOW IF IT WAS FROM THE AMPLATZER VASCULAR PLUG DEVICE ITSELF, BUT LEANED TOWARDS THAT SINCE THEY HAVE CLOSED MANY INTERNAL ILIACS WITH COILS WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLAZTER VASCULAR PLUG ARTERIAL EMBOLIZATION DEVICE KRD AGA MEDICAL CORP. 9-PLUG-000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other