BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA

    MDR report key: 3771381 · Received April 24, 2014

    Report

    Report Number
    2953200-2014-00831
    Event Type
    Death
    Date Received
    April 24, 2014
    Date of Event
    September 27, 2011
    Report Date
    April 6, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: CEC ADJUDICATED THE EVENT AS ANEURYSM RELATED, DEVICE RELATED AND PROCEDURE RELATED.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM IN ZONES 3 AND 4. A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS ALSO IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THERE WAS AN ENLARGING SUPRARENAL AAA. THE SITE HAD BEEN WATCHING THE ENLARGING AAA AND ON AN UNSCHEDULED VISIT, A TYPE IB ENDOLEAK AT THE DISTAL END OF THE TAA WAS DISCOVERED. IT WAS ALSO REPORTED THAT THE PATIENT SUFFERED FROM A TYPE IA ENDOLEAK AND A TYPE III JUNCTIONAL ENDOLEAK. THE TYPE III WAS FROM THE UN-STENTED RENAL FENESTRATIONS. THE TYPE IA ENDOLEAK WAS RESOLVED. THE PROCEDURE WAS ABANDONED AFTER 3-4 HOURS SINCE THE PHYSICIAN COULD ONLY CANNULATE THE SUPERIOR MESENTERIC ARTERY. THE PHYSICIAN COULD NOT CANNULATE THE RENAL AND HEPATIC ARTERIES, BUT THE RENAL ARTERIES WERE BEING SUPPLIED THROUGH THE FENESTRATION VERY WELL. AT THE END OF THE PROCEDURE, THE PATIENT HAD A TYPE III ENDOLEAK THROUGH THE FENESTRATIONS. THE ENDOLEAK WAS NOT SEEN ON A SUBSEQUENT CT SCAN. THEY SCHEDULED THE PATIENT FOR A FEVAR OF 4 VESSELS. A SECONDARY ENDOVASCULAR PROCEDURE WAS PERFORMED. THE PATIENT WAS REPORTED TO HAVE A VERY TORTUOUS AORTIC ARCH AND DESCENDING THORACIC AORTA. THE RENAL ARTERIES WERE VERY DISEASED AND APPROXIMATELY 3 MM IN DIAMETER. THE VALIANT STENT GRAFTS WERE IMPLANTED IN THE DESCENDING THORACIC AORTA, AND ANOTHER MANUFACTURER'S DEVICE, (COOK), WAS IMPLANTED ACROSS THE VISCERAL VESSELS. EVENT RESOLVED AND THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSMENT STATES THAT THE EVENT IS NOT RELATED TO THE DEVICE OR PROCEDURE. FOUR MONTHS AFTER THE SECONDARY PROCEDURE, THE PATIENT WAS SEEN IN A HOSPITAL EMERGENCY DEPARTMENT. THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION, AND WAS PRESCRIBED BACTRIM TO TREAT THE INFECTION. IT WAS REPORTED THAT THE PATIENT LATER DIED. THE DEATH CERTIFICATE LISTS THE CAUSE OF DEATH AS SEPSIS DUE TO PARAPLEGIA DUE TO SPINAL ARTERY EMBOLISM. THE INVESTIGATOR STATES THAT THE EVENT IS NOT RELATED TO THE DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249457 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00191721

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Death