BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 644858 · Received November 4, 2005

    Report

    Report Number
    2953200-2005-01329
    Event Type
    Injury
    Date Received
    November 4, 2005
    Date of Event
    September 6, 2005
    Report Date
    October 6, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 28 MM DIAMETER X 16 MM DIAMETER X 13.5 CM LENGTH ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. PT HAD A HISTORY OF CORONARY ARTERY DISEASE, PERIPHERAL VASCULAR DISEASE AND MYOCARDIAL INFARCTION. ANEURYSM AND VESSEL MORPHOLOGY ARE UNKNOWN. IT WAS REPORTED THAT THE STENT GRAFT MIGRATION AND SUBSEQUENTLY A PROXIMAL TYPE I ENDOLEAK DEVELOPED. THIRTY FOUR MONTHS POST STENT GRAFT IMPLANTATION A REQUEST FOR A TALENT AORTIC CUFF UNDER IDE (G020050) WAS REQUESTED AND A 32 MM DIAMETER X 35 MM DIAMETER TALENT AORTIC CUFF WAS SUCCESSFULLY IMPLANTED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS REPORTED TO THE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT AAA STENT GRAFT MIH MEDTRONIC VASCULAR NA M02L552055

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention