BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 631795 · Received July 29, 2005

    Report

    Report Number
    2953200-2005-01252
    Event Type
    Injury
    Date Received
    July 29, 2005
    Date of Event
    July 29, 2005
    Report Date
    July 29, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN UNKNOWN SIZE ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY ARE UNKNOWN. IT WAS REPORTED THAT THE AORTIC NECK HAD DILATED AND THE STENT GRAFT MIGRATED. CURRENTLY THERE IS A SMALL TYPE I ENDOLEAK PRESENT AND THE PHYSICIAN HAD REQUESTED A TALENT AORTIC CUFF, UNDER TALENT AORTIC CUFF TRIAL (IDE-G020050) TO BE USED FOR TREATMENT OF THE PT. IT WAS REPORTED ANOTHER MANUFACTURER'S DEVICE IS AVAILABLE FOR USE; THEREFORE, THE TALENT CUFF WAS NOT AN OPTION FOR USE. NO ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE PATIENT WILL BE CLOSELY MONITORED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention