BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX UNK - US

    MDR report key: 621325 · Received July 15, 2005

    Report

    Report Number
    2953200-2005-01188
    Event Type
    Injury
    Date Received
    July 15, 2005
    Report Date
    June 26, 2004
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED POST STENT GRAFT IMPLANTATION A REQUEST FOR A TALENT AORTIC CUFF UNDER IDE (G020050) WAS REQUESTED. THE PHYSICIAN REQUESTED INFORMATION DUE TO A TYPE I ENDOLEAK, THE CAUSE OF TYPE I ENDOLEAK IS UNKNOWN. PER MEDTRONIC TALENT AORTIC CUFF APPROVED PROTOCOL, MEDTRONIC SENT THE SITE THE DOCUMENTATION REQUIRED FOR EACH REQUEST TO COMPLETE FOR APPROVAL FOR THE TALENT AORTIC CUFF TRIAL. HOWEVER, THE REQUESTER DID NOT RETURN THE REQUIRED DOCUMENTATION; THEREFORE NO TALENT AORTIC CUFF TRIAL DEVICE WAS SENT. THERE WAS NO FURTHER INFORMATION PROVIDED TO MEDTRONIC ABOUT THE REQUEST FOR THE DEVICE OR THE DETAILS OF THE PATIENT TO THE ANEURX DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX UNK - US AAA STENT GRAFT MIH MEDTRONIC VASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other