BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1696656 · Received May 21, 2010

    Report

    Report Number
    2953200-2010-00920
    Event Type
    Death
    Date Received
    May 21, 2010
    Date of Event
    April 22, 2010
    Report Date
    April 22, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVALUATION RESULTS: DEATH, ENDOLEAK; PRE-OPERATIVE RUPTURING THORACIC AORTIC ANEURYSM. CONCLUSION: PRE-OPERATIVE THORACIC AORTIC DISSECTION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT DEVICE WAS IMPLANTED INTO A PT FOR THE EMERGENT TREATMENT OF A RUPTURING THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT PRIOR TO DEPLOYMENT COMPLETION, THE PHYSICIAN WAS PREPARING TO TAKE IMAGES, THE STENT GRAFT MOVED AND ENDED UP IN THE ANEURYSM SAC (MFR# 2953200-2010-00919). ANOTHER TALENT PROXIMAL MAIN STENT GRAFT WAS IMPLANTED AND LANDED PERFECTLY AT THE CAROTID ARTERY, AND THEN TWO MORE TALENT DEVICES WERE IMPLANTED. THERE APPEARED TO BE A GOOD SEAL AT THE END OF THE CASE. THE PT PRESENTED FOR 30 DAY FOLLOW-UP AND A ROUTINE CT DEMONSTRATED THERE MIGHT BE A TYPE III ENDOLEAK. THE PHYSICIAN PLANNED ON TREATING THE PT IN THE NEAR FUTURE. IT WAS REPORTED THAT THE PT WAS HOME AND BECAME HYPOTENSIVE. THE PT WAS TAKEN EMERGENTLY TO THE HOSPITAL, DUE TO LOSS OF BLOOD PRESSURE. DURING THE TRANSPORTATION, THE PT CODED AND EXPIRED. IT WAS REPORTED THAT AN AUTOPSY WAS PERFORMED AND IT WAS NOTED THAT THERE WAS A TYPE III ENDOLEAK. (MFR # 2953200-2010-00921 AND MFR # 2953200-2010-00922).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00188327

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death