BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1712884 · Received June 4, 2010

    Report

    Report Number
    2953200-2010-01076
    Event Type
    Death
    Date Received
    June 4, 2010
    Date of Event
    May 19, 2010
    Report Date
    May 19, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION, RESULTS: DEATH, RUPTURE. LARGE ANEURYSM AND ANGULATED AORTIC NECK. PT WAS LOST TO FOLLOW-UP. EVALUATION, CONCLUSIONS: LARGE ANEURYSM AND ANGULATED AORTIC NECK. PT WAS LOST TO FOLLOW-UP.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 10.9 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 4 YEARS AGO. THE AORTIC NECK WAS 27 MM IN DIAMETER WITH SOME ANGULATION. THE PT WAS LOST TO FOLLOW-UP BUT RETURNED TO THE HOSPITAL 6 MONTHS AGO. IT WAS NOTED THAT THE BIFURCATED STENT GRAFT WAS LOCATED SOME UNK DISTANCE BELOW THE RENAL ARTERIES AND IT MAY HAVE BEEN PLACED LOW AT THE TIME OF IMPLANT; HOWEVER, THERE WAS NO ENDOLEAK AND NO REPORTED MIGRATION. THE ANEURYSM WAS LARGE AT 10.9 CM. THE DECISION WAS MADE TO BUILD THE BIFURCATED STENT GRAFT UP TO THE LEVEL OF THE RENAL ARTERIES WITH 2 ANEURX 28 MM CUFFS AND A TALENT 34 MM CUFF (SEE MFR # 2953200-2010-01075). THE FIRST ANEURX CUFF WAS PLACED AT THE GATE OF THE BIFUR AND AT THE 6 MONTH CT FOLLOW-UP, THE ANEURYSM DIAMETER WAS 10.1 CM WITH NO ENDOLEAK VISIBLE. FIVE DAYS LATER, THE PT PRESENTED EMERGENTLY WITH FLANK PAIN; HOWEVER, THERE WAS NO ENDOLEAK OR RUPTURE ON CT. THE PT WAS THOUGHT TO BE STABLE AND WAS MOVED TO THE ICU, BUT EXPIRED A SHORT TIME LATER FROM A RUPTURED ANEURYSM. IT IS LIKELY THAT THERE WAS A SMALL HOLE (TYPE 3 ENDOLEAK) MAY BE PRESENT ABOVE THE GATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00363579

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death