BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1734603 · Received June 22, 2010

    Report

    Report Number
    2953200-2010-01187
    Event Type
    Death
    Date Received
    June 22, 2010
    Date of Event
    December 1, 2009
    Report Date
    May 24, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVAL RESULTS: DEATH; ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED, UNK REASON FOR INTERVENTION AND CAUSE OF DEATH. CONCLUSION: ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED, UNK REASON FOR INTERVENTION AND CAUSE OF DEATH.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT DEVICE WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM APPROXIMATELY 18 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. THE PATIENT HAD A SECOND INTERVENTION 11 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR AN UNK REASON. IT WAS REPORTED THAT THE PATIENT EXPIRED APPROXIMATELY A WEEK AFTER THIS INTERVENTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00177893

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death