BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (HDM FLEXIBLE) WITH XPEDIENT

    MDR report key: 622465 · Received June 23, 2005

    Report

    Report Number
    2953200-2005-01226
    Event Type
    Injury
    Date Received
    June 23, 2005
    Date of Event
    June 20, 2005
    Report Date
    June 23, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 26 MM DIAMETER X 15 MM DIAMETER X 16.5 CM ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM SIZE AT THE TIME OF IMPLANT WAS 4.8 CM. THE VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED 7 MONTHS POST STENT GRAFT IMPLANTATION, A CT DEMONSTRATED A PROXIMAL TYPE I ENDOLEAK. THE AORTIC NECK HAS EXPLANDED DUE TO DISEASE PROGRESSION. THE PHYSICIAN HAS REQUESTED A TALENT ACORTIC CUFF UNDER IDE (G020050) WAS REQUESTED FOR REPAIR OF THE TYPE I ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT (HDM FLEXIBLE) WITH XPEDIENT AAA STENT GRAFT MIH MEDTRONIC VASCULAR NA 290861

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention