BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AENURX - UNK

    MDR report key: 664985 · Received January 17, 2006

    Report

    Report Number
    2953200-2006-00013
    Event Type
    Injury
    Date Received
    January 17, 2006
    Date of Event
    December 18, 2005
    Report Date
    December 18, 2005
    Manufacturer
    MEDTRONIC VASCULAR SANTA ROSA
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN UNKNOWN SIZE ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY IS UNKNOWN AND IT WAS REPORTED THE AORTIC NECK WAS ORIGINALLY 28MM IN DIAMETER AND IT CURRENTLY MEASURES 31MM IN DIAMETER. THE STENT GRAFT WAS ORIGINALLY IMPLANTED 1 CM BELOW THE RENAL ARTERIES AND CURRENTLY IT IS 2CM BELOW THE RENAL ARTERIES. THE PHYSICIAN CONTACTED MEDTRONIC AND STATED THAT A TALENT CUFF UNDER IDE (G020050) MAY BE REQUIRED FOR TREATMENT OF THE PATIENT AND THAT HE WOULD CONTACT MEDTRONIC BACK IF HE IS OPTING TO USE THE TALENT CUFF. THE PHYSICIAN HAS NOT CONTACTED MEDTRONIC TO FINALIZE THE TALENT CUFF REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AENURX - UNK AAA STENT GRAFT MIH MEDTRONIC VASCULAR SANTA ROSA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention