BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1706379 · Received May 28, 2010

    Report

    Report Number
    2953200-2010-00962
    Event Type
    Death
    Date Received
    May 28, 2010
    Date of Event
    April 28, 2010
    Report Date
    April 28, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVAL RESULTS: DEATH; PRE-OPERATIVE RUPTURED ANEURYSM.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 32-36 MM IN DIAMETER AND 12 MM IN LENGTH WITH MILD THROMBUS. THE RIGHT ILIAC WAS MILDLY TORTUOUS AND NON-CALCIFIED, BUT THERE WAS SOME CALCIFICATION AT THE ILIAC BIFURCATION. IT WAS REPORTED THAT A GLIDEWIRE DISSECTED THE RIGHT ILIAC ARTERY PRIOR TO STENT GRAFT INSERTION. THERE WERE NO ISSUES WHEN ADVANCING THE DEVICES AND THE TALENT STENT GRAFT SYSTEM WAS SUCCESSFULLY IMPLANTED AND COVERING THE DISSECTION. IT WAS REPORTED THAT THE FOLLOWING DAY, THE PATIENT'S BLOOD PRESSURE DROPPED, AND THE PT WAS BROUGHT BACK TO THE OPERATING ROOM, AS THERE MAY HAVE BEEN AN ENDOLEAK. THE PATIENT CODED ON THE TABLE FROM CARDIAC ARREST BEFORE THE PHYSICIAN COULD PERFORM AN INTERVENTION. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00417708

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death