BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE

    MDR report key: 799021 · Received December 20, 2006

    Report

    Report Number
    2954310-2006-81415
    Event Type
    Injury
    Date Received
    December 20, 2006
    Date of Event
    December 20, 2006
    Report Date
    December 20, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN WAS FAXED INFORMATION REGARDING THE ANCURE ENDOGRAFT AND MRI SINCE THE MFR UTILIZES SAME MAGNETIC RESONANCE TECHNOLOGY.

    Description of Event or Problem · 1

    PHYSICIAN CALLED TODAY TO REPORT THAT HIS PATIENT IS EXPERIENCING GROWTH OF THE ANEURYSM SAC OF UNKNOWN ORIGIN. CT (NO CONTRAST) HAS NOT SHOWN ENDOLEAK. PATIENT DOES HAVE RENAL INSUFFICIENCY; AT THIS POINT, PHYSICIAN DOES NOT FEEL IT IS RELATED TO THE GRAFT. PHYSICIAN IS CONSIDERING PERFORMANCE OF AN MRA (MAGNETIC RESONANCE ANGIOGRAM) IN HOPES OF IDENTIFYING THE CAUSE OF THE SAC GROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCURE GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS 13443 *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other