BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 1000528 · Received February 20, 2008

    Report

    Report Number
    2953200-2008-00068
    Event Type
    Death
    Date Received
    February 20, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 25, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    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

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF A 4.4CM ABDOMINAL AORTIC ANEURYSM. THE OPERATIVE NOTES AT THE 6 MONTH FOLLOW UP STATED THAT THE ANEURYSM HAD SHRANK TO 3.7CM, THERE WERE NO ENDOLEAKS RELATING TO THE ANEURYSMAL STENT AND THAT THE RENAL ARTERY WAS PREVIOUSLY NOTED TO BE ASYMMETRY IN NEPHROGRAM PHASE SUGGESTING A PRIOR STENOSIS WHICH HAS PROGRESSES SINCE THE PRIOR ANGIOGRAM. ONE MONTH LATER, THE PT PRESENTED FOR A FOLLOW-UP AND THE OPERATIVE NOTES STATES THAT THE ENDOGRAFT IS IN GOOD POSITION WITH NO ENDOLEAKS AND THE RENAL ARTERY IS COMPLETELY OCCLUDED. THE PHYSICIAN TREATED THE LEFT RENAL ARTERY WITH ANGIOPLASTY AND STENTING OF THE TOTALLY OCCLUDED LEFT RENAL ARTERY. THE PT PRESENTED THE FOLLOWING WEEK EMERGENTLY DUE TO A SYNCOPE EPISODE, THE PT HAS FALLEN AND THE CT DEMONSTRATED A HEMORRHAGIC CONTUSION TO THE PT'S HEAD. THE PHYSICIAN BELIEVES THAT THE MASSIVE LEFT FRONTAL-TEMPORAL BLOOD CLOT WAS NOT TREATABLE OR REVERSIBLE. THE PT WAS REMOVED FROM LIFE SUPPORT AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 1000196

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death