BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT AAA

    MDR report key: 3909751 · Received July 2, 2014

    Report

    Report Number
    2953200-2014-01348
    Event Type
    Death
    Date Received
    July 2, 2014
    Date of Event
    April 1, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXACT DATE OF DEATH IS UNKNOWN. EVAL: OFF-LABEL, UNAPPROVED OR CONTRAINDICATED USE (PRE-OPERATIVE RUPTURE).

    Description of Event or Problem · 1

    THE TALENT AUI IS NOT APPROVED. A MALFUNCTION TO SIMILAR DEVICE DID NOT OCCUR. THIS MEDWATCH REPORT IS REDACTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. FUNGAL INFECTION OF AORTIC ENDOGRAFT DUE TO ASPERGILLUS FUMIGATUS EMANUELE FERRERO , MICHELANGELO FERRI , ANDREA VIAZZO , ALESSANDRA TREVISAN, DANIELE PSACHAROPULO , MATTEO RIPEPI , LORENZO GIBELLO , FRANCO NESSI 10.1016/J.AVSG.2014.04.012 THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: FEVER, INFECTION, DEATH, RIGHT ILIAC THROMBOSIS, THROMBOSIS INTO THE EXTERNAL ILIAC AND LEFT SUPERFICIAL FEMORAL ARTERY NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. ABSTRACT (B)(6) YEAR-OLD MALE, REFERRED TO OUR CENTRE WITH A RUPTURED AORTIC ANEURYSM, UNDERWENT URGENT ENDOVASCULAR REPAIR WITH TALENT AUI AND FEMORO-FEMORAL CROSSOVER BYPASS. AN ENDOGRAFT INFECTION DUE TO ASPERGILLUS FUMIGATUS OCCURRED ABOUT 20 DAYS AFTER SURGERY. WE REMOVED THE ENDOGRAFT AND FEMORALS PROSTHESIS AND WE THEN PERFORMED AN AORTO-BI-ILIAC BYPASS WITH AUTOGENOUS REVERSED SUPERFICIAL FEMORAL VEINS. FIVE DAYS AFTER SURGERY THE PATIENT DIED. MICROBIOLOGICAL EXAMINATION AND POST MORTEM EXAM SHOWED THE PRESENCE OF ASPERGILLUS FUMIGATUS BOTH IN FEMORALS PROSTHESIS, IN AORTIC WALL AND PERIAORTIC EXUDATE. THE AUTHORS NOTE, "HOWEVER, RETROSPECTIVELY,THE PRESENCE OF A THROMBUS AT THE LEVEL OF THE COMMON ILIAC ARTERY AND THE RUPTURE OF ABDOMINAL AORTA, SUGGEST THAT THE INFECTION COULD HAVE BEEN ALREADY PRESENT BEFORE ENDOVASCULAR TREATMENT,EVEN IF WE EXCLUDED THIS HYPOTHESIS AT FIRST." CONCLUSION TO OUR KNOWLEDGE, WE REPORT THE FIRST CASE OF AN ABDOMINAL AORTIC EG INFECTION DUE TO ASPERGILLUS FUMIGATUS FUNGUS. INFECTION OF ABDOMINAL AORTIC EG IS A RARE EVENT, CHARACTERIZED BY HIGH MORBIDITY/MORTALITY AND ITS MANAGEMENT IS STILL A CHALLENGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388520 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Death