BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1790056 · Received August 6, 2010

    Report

    Report Number
    2953200-2010-01516
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 9, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    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): RESULTS: (DISSECTION), (SEVERELY CALCIFIED VESSELS).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM AND A TYPE 1 B DISSECTION WHICH STARTED BELOW THE THORACIC ARCH APPROXIMATELY 2 MONTHS AGO. THE EXTERNAL ILIAC AND COMMON FEMORAL ARTERIES WERE SEVERELY CALCIFIED, AND THE ILIAC VESSEL DIAMETER WAS 7-9 MM IN DIAMETER. THE PATIENT HAD A CABG AND BILATERAL CAROTID BYPASS PROCEDURES DONE IN THE PAST. IT WAS REPORTED THAT A TALENT THORACIC CLINICAL TRIAL DEVICE WAS USED AS THE PROXIMAL MAIN, 2 TALENT THORACIC DISTAL MAIN STENT GRAFTS AND 1 TALENT DEVICE THROUGH THE CALCIFIED AREA. THE DELIVERY SYSTEM COULD NOT BE ADVANCED AND KINKED. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT (SEE MFR # 2953200-2010-01515). THE ARTERIOGRAM SHOWED A SHORT SEGMENT DISSECTION IN THE RIGHT EXTERNAL ILIAC ARTERY BELOW THE INTERNAL AND COMMON ARTERY BIFURCATION. A 9 X 40 MM BRIDGE ASSURANT STENT WAS PLACED OVER THIS DISSECTED AREA WITH EXCELLENT RESULTS, AND THERE WAS GOOD FLOW. UPON REMOVAL OF ALL THE SHEATHS AND INTRODUCERS FROM THE RIGHT SIDE, THERE WAS A FOCAL DISSECTION WHERE THE STENT GRAFT DELIVERY SYSTEMS WERE INSERTED (SEE MFR # 2953200-2010-01517 AND MFR # 2953200-2010-01518). THIS AREA IN THE COMMON FEMORAL ARTERY WAS EXCISED AND REPLACED WITH A GORE-TEX INTERPOSITION AND RESOLVED THE DISSECTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention