BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1715975 · Received June 9, 2010

    Report

    Report Number
    2953200-2010-01111
    Event Type
    Death
    Date Received
    June 9, 2010
    Date of Event
    May 13, 2010
    Report Date
    May 13, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVAL RESULTS AND CONCLUSIONS: DEATH. PAPER THIN AORTA.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 7-8 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE VESSELS HAD SOME CALCIFICATION. THE AORTIC NECK WAS 2 CM LONG, IT WAS 18.5-19 MM IN DIAMETER AT THE LEVEL OF THE RENAL ARTERIES, AND IT MAY HAVE ENLARGED SLIGHTLY AT 1.5 CM BELOW THE RENAL ARTERIES. IT CONTAINED MILD CALCIFICATION AND IT WAS ANGULATED AT 45 DEGREES. THE AORTA WAS DESCRIBED AS BEING ABNORMALLY THIN. IT WAS REPORTED THAT AFTER THE BIFURCATED STENT GRAFT WAS IMPLANTED, THERE WAS A PROBABLE PROXIMAL TYPE 1 ENDOLEAK AND/OR BLUSH AND FILLING OF THE SAC, WHICH WAS RESOLVED BY BALLOONING. THERE WAS STILL A LATE BLUSH, BUT THE IDENTITY OF THE LEAK AND CONFIRMATION OF A LEAK COULD BE NOT DETERMINED. THE DECISION WAS MADE TO END THE PROCEDURE AND NOT INTERVENE FURTHER. LATER THE SAME DAY, THE PT'S PRESSURES STARTED DROPPING, AND THE PULSE IN ONE OF THE LEGS WAS ABSENT. THE PT WAS BROUGHT BACK TO THE OPERATING ROOM, AND AN ANGIOJET WAS USED TO REMOVE CLOT ON THE IPSILATERAL SIDE. THE CLOT WAS APPARENTLY STABILIZING A PERFORATION OF THE AORTA, LATER FOUND TO BE CAUSED BY ONE OF THE BARE SPRINGS OF THE TALENT BIFURCATED STENT GRAFT. ONCE THE CLOT WAS REMOVED, THE PT BLED OUT. THE ABDOMEN WAS OPENED, AND A PERFORATION OF THE AORTA WAS NOTED. THE AORTA WAS FOUND TO BE UNUSUALLY "PAPER-THIN". THE PT EXPIRED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA V00131754N

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death