BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT

    MDR report key: 3180831 · Received June 20, 2013

    Report

    Report Number
    2953200-2013-01162
    Event Type
    Death
    Date Received
    June 20, 2013
    Date of Event
    July 23, 2012
    Report Date
    May 27, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (DEATH), (LACK OF INFORMATION, CAUSE OF EVENT IS UNKNOWN). CONCLUSION: (LACK OF INFORMATION, CAUSE OF EVENT IS UNKNOWN), KNOWN INHERENT RISK OF A PROCEDURE (DEATH).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF FUSIFORM 5.5 CM DIAMETER AND 9.4 CM IN LENGTH THORACIC AORTIC ANEURYSM IN ZONE 2 AND 3. HEALTHY BLOOD VESSEL. THE DIAMETER OF THE PROXIMAL SIDE IS 37 MM AND THE DIAMETER OF THE DISTAL SIDE IS 33 MM. ONE MONTH POST INDEX PROCEDURE A TYPE I ENDOLEAK WAS NOTED, THE PATIENT WAS MONITORED BY THEIR PHYSICIAN. THE INVESTIGATOR ASSESSMENT STATES RELATIONSHIP TO THE PRODUCT IS UNKNOWN, RELATIONSHIP TO PROCEDURE IS UNKNOWN. A YEAR LATER THE ANEURYSM HAS EXPANDED TO 103MM IN DIAMETER. A SECONDARY INTERVENTION WAS PERFORMED AND ANOTHER MANUFACTURER¿S STENT GRAFT WAS IMPLANTED. AN ADDITIONAL STENT GRAFT WAS IMPLANTED FOR LTCCA (SINGLE CHIMNEY). AS A RESULT, ENDOLEAK RESOLVED. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO SUBARACHNOID HEMORRHAGE AT ANOTHER FACILITY. THE INVESTIGATOR ASSESSMENT STATES RELATIONSHIP TO THE PRODUCT IS UNKNOWN, RELATIONSHIP TO PROCEDURE IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280337 TALENT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death