BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 621361 · Received July 15, 2005

    Report

    Report Number
    2953200-2005-01191
    Event Type
    Injury
    Date Received
    July 15, 2005
    Date of Event
    February 4, 2004
    Report Date
    February 9, 2004
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 28 MM DIAMETER X 16 MM DIAMETER X 16.5 CM ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF A 7 CM ABDOMINAL AORTIC ANEURYSM. VESSEL TORTUOSITY WAS MINIMAL WITH MINIMAL CALCIFICATION. IT WAS REPORTED THAT SEVERAL WEEKS POST STENT GRAFT IMPLANT THE PT UNDERWENT RESECTION OF THEIR COLON DUE TO CANCER. THE PT RETURNED FOR A SIX-MONTH FOLLOW-UP AND THE CT DEMONSTRATED EXPANSION OF THE AORTIC NECK RESULTING IN A TYPE I ENDOLEAK; THERE WAS NO EVIDENCE OF STENT GRAFT MIGRATION. SIX MONTHS POST STENT GRAFT IMPLANTATION A REQUEST FOR A TALENT AORTIC CUFF UNDER IDE (G020050) WAS REQUESTED. THE PT IS NOT A SURGICAL CANDIDATE DUE TO PT'S AGE, HEALTH STATUS AND CO-MORBIDITIES. THE PHYSICIAN IMPLANTED A TALENT AORTIC CUFF AND THE TYPE I ENDOLEAK WAS RESOLVED. THE PHYSICIAN ELECTED TO IMPLANT A SECOND TALENT AORTIC CUFF BETWEEN THE GRAFTS WITH EXCELLENT RESULTS.

    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 M03C553525

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention