BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1696185 · Received May 20, 2010

    Report

    Report Number
    2953200-2010-00893
    Event Type
    Death
    Date Received
    May 20, 2010
    Date of Event
    April 22, 2010
    Report Date
    April 22, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION RESULTS: DEATH, ARTERIAL TRAUMA/DISSECTION/PERFORATION. PRE-OPERATIVE THORACIC AORTIC DISSECTION AND VESSEL DIAMETER WAS 7 MM.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT DEVICE WAS IMPLANTED INTO A PT FOR THE EMERGENT TREATMENT OF A THORACIC AORTIC ANEURYSM. THE ILIAC VESSEL DIAMETER WAS 7 MM, AND THERE WAS MILD CALCIFICATION. THE THORACIC STENT GRAFT WAS SUCCESSFULLY IMPLANTED, HOWEVER, UPON THE REMOVAL OF THE DELIVERY CATHETER, THERE WAS SOME RESISTANCE RESULTING IN EVULSION OF A PART OF THE ILIAC VESSEL. (MFR# 2953200-2010-00893). IT WAS REPORTED THAT THE PT HAD ISSUES WITH ANESTHESIA, THE ANESTHESIOLOGIST HAD DIFFICULTIES LOWERING THE PT'S BLOOD PRESSURE. THE PHYSICIAN BELIEVES THAT SINCE THE DELIVERY CATHETER REMAINED IN THE PT APPROXIMATELY 18-20 MINUTES, IT MAY HAVE CONTRIBUTED TO THE ILIAC EVULSION, DUE TO THE VASOSPASMING OF THE VESSEL. THE PT LOST A LARGE AMOUNT OF BLOOD, WITH A TOTAL BLOOD TRANSFUSION WAS PERFORMED. THE PHYSICIAN INSERTED AND IMPLANTED TWO ANEURX ILIAC LIMB DEVICES IN THE ILIAC ARTERY, BUT THE STENT GRAFT ILIAC LIMB WAS ONLY PARTIALLY IN THE VESSEL, AND THE SECOND DEVICE WAS INSIDE OF THE FIRST STENT GRAFT. THERE WAS NO VESSEL FOR THE STENT GRAFT TO ADHERE TO, SO THE PHYSICIAN ELECTED TO REMOVE THE ANEURX STENT GRAFTS AND CONVERT THE PT TO A DACRON STENT GRAFT. (MFR# 2953200-2010-00894 AND MFR# 2953200-2010-00895). THE PT WAS CLOSED AND SENT TO ICU. IT WAS REPORTED THAT THE PT EXPIRED THE FOLLOWING DAY, DUE TO THE COMPLICATIONS FOLLOWING THE LARGE AMOUNT OF BLOOD LOSS. 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 GALWAY NA V00425167

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death