BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT CAPTIVIA

    MDR report key: 4221071 · Received November 3, 2014

    Report

    Report Number
    2953200-2014-02272
    Event Type
    Death
    Date Received
    November 3, 2014
    Date of Event
    October 5, 2014
    Report Date
    April 6, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT THE PRIMARY CAUSE OF DEATH WAS RESPIRATORY FAILURE, MEDIALSTINAL HEMATOMA, DESCENDING THORACIC AORTIC ANEURYSM. AN AUTOPSY WAS PERFORMED AND THE STENT GRAFTS WERE EXPLANTED, BUT WERE NOT RETURNED. THE INVESTIGATOR ASSESSED THIS EVENT AS NOT DEVICE OR PROCEDURE RELATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: CTA AT THE TIME OF DEATH REVEALED A TYPE IA ENDOLEAK INTO THE ANEURYSM SAC BETWEEN THE ATTACHMENT SITE OF THE STENT GRAFT AND THE NATIVE AORTIC WALL. A LARGE MEDIASTINAL HEMATOMA, PROBABLY FROM RUPTURE OF THE ANEURYSM SAC WAS COMPRESSING THE LEFT ATRIUM. THE CEC ADJUDICATED THE EVENT AS ANEURYSM AND DEVICE RELATED AND NOT PROCEDURE RELATED WITH CAUSE OF DEATH AS RUPTURED THORACIC ANEURYSM.

    Description of Event or Problem · 1

    A TALENT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A GREATER THAN 6 CM DIAMETER THORACIC AORTIC ANEURYSM. THE PATIENT HAD A PRE-EXISTING ASCENDING AORTA SURGICAL GRAFT REPLACEMENT. APPROXIMATELY 3.5 YEARS POST IMPLANT THE PATIENT'S DAUGHTER CALLED TO INFORM OF THE DEATH OF THE PATIENT OCCURRED AT ANOTHER HOSPITAL. THE PATIENT HAD COMPLAINED OF CHEST PAIN AND HYPOTENSION. CAUSE OF DEATH IS UNKNOWN AT THIS TIME PER THE INVESTIGATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703134 TALENT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00534912

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Death