BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2770981 · Received October 3, 2012

    Report

    Report Number
    2953200-2012-01907
    Event Type
    Death
    Date Received
    October 3, 2012
    Date of Event
    July 21, 2010
    Report Date
    September 5, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, DEATH). UNKNOWN CAUSE OF ENDOLEAK CONCLUSION: UNKNOWN CAUSE OF ENDOLEAK.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 7 CM THORACIC AORTIC ANEURYSM AT ZONE 4 APPROXIMATELY 26 MONTHS AGO. THE PROXIMAL NECK WAS 42 MM IN DIAMETER AND THE DISTAL NECK WAS 37 MM IN DIAMETER. THERE WAS NO THROMBUS OR CALCIFICATION. IT WAS REPORTED THAT THE PHYSICIAN REMODELLED THE STENT GRAFT, HOWEVER A TYPE IA ENDOLEAK WAS DISCOVERED. NO INTERVENTION WAS PERFORMED; ONE MONTH POST IMPLANTATION THE TYPE IA ENDOLEAK WAS STILL PRESENT. THE ONE YEAR NON-CONTRAST CT SCAN WAS PERFORMED; THE PRESENCE OF AN ENDOLEAK COULD NOT BE DETERMINED SINCE THERE WAS NO CONTRAST. THE ANEURYSM DIAMETER WAS 7.1 CM, SO THE PHYSICIAN DECIDED TO CONTINUE TO MONITOR THE PATIENT. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO PNEUMONIA AFTER WORSENING RENAL FAILURE. THE PHYSICIAN COMMENTED THAT THE DEATH WAS NOT RELATED TO THE DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00312777

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Death