BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1841641 · Received September 16, 2010

    Report

    Report Number
    2953200-2010-01756
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 17, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ENDOLEAK), (EMERGENT PENETRATING ULCER WITH HEMATOMA), (IMPLANTATION OF AN ILIAC DEVICE IN THE THORACIC AORTA FOR AN ULCER). CONCLUSION: (EMERGENT PENETRATING ULCER WITH HEMATOMA), (IMPLANTATION OF AN ILIAC DEVICE IN THE THORACIC AORTA).

    Description of Event or Problem · 1

    A TALENT ILIAC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A SYMPTOMATIC 3 MM IN DIAMETER FOCAL PENETRATING ULCER, LOCATED IN THE DESCENDING THORACIC AORTA ABOUT 8 CM ABOVE THE CELIAC ARTERY. THE ULCER LEAKED INTO A 4-5 CM IN DIAMETER HEMATOMA. THERE WAS CIRCUMFERENTIAL CALCIFICATION THROUGHOUT THE ILIAC ARTERIES AND THE AORTA. ILIAC ARTERIES WERE 6 MM IN DIAMETER. IT WAS REPORTED THAT THE PATIENT WAS TOO ILL FOR A CONDUIT INCISION AND, DUE TO THE NARROW, CALCIFIED VESSELS, A TALENT THORACIC DEVICE WAS NOT SELECTED FOR USE. INSTEAD, THREE SMALLER DEVICES, WHICH INCLUDED TWO ANEURX 24 MM CUFFS AND A TALENT 22 MM LIMB, WERE SELECTED AND IMPLANTED SUCCESSFULLY WITH THE TALENT LIMB PLACED IN THE MIDDLE OF THE TWO ANEURX CUFFS. AN ILIAC STENT FROM ANOTHER MANUFACTURER WAS INTENTIONALLY IMPLANTED FOR THE EASY DELIVERY OF THE DEVICES. A TYPE II ENDOLEAK WAS PRESENT AT THE END OF THE CASE AND LEFT UNTREATED. APPROXIMATELY 10 DAYS POST-IMPLANTATION, A TRANSGRAFT LEAK IN THE TALENT LIMB WAS NOTED, AND THE PHYSICIAN ELECTED TO PLACE TWO CUFFS FROM ANOTHER MANUFACTURER TO TRY TO RESOLVE THE LEAK; THE LEAK WAS REDUCED BUT DID NOT RESOLVE COMPLETELY. NO FURTHER INTERVENTION WAS DONE AT THE TIME. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00448569

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention