BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1772391 · Received July 23, 2010

    Report

    Report Number
    2953200-2010-01382
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 23, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - LARGE INNOMINATE ARTERY OSTIUM; ASCENDING AORTIC ANEURYSM. IMPLANTATION TO THE CAROTID ARTERY. CONCLUSIONS - LARGE INNOMINATE ARTERY OSTIUM; ASCENDING AORTIC ANEURYSM. IMPLANTATION TO THE CAROTID ARTERY.

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.9 CM THORACIC AORTIC ANEURYSM. THE PATIENT ALSO HAS A GREATER THEN 4.6 CM IN DIAMETER ASCENDING AORTIC ANEURYSM. THE ORIGIN OF THE INNOMINATE ARTERY IS VERY WIDE AT 1 CM IN DIAMETER. VESSEL MORPHOLOGY WAS REPORTED AS NO TORTUOSITY AND NO CALCIFICATION. THE PHYSICIAN PERFORMED A CAROTID-SUBCLAVIAN BYPASS PRIOR TO THE STENT GRAFT IMPLANT AND SELECTED THE LEFT CAROTID ARTERY AS THE INTENDED LANDING ZONE. IT WAS REPORTED THE PHYSICIAN INSERTED THE FIRST TALENT STENT GRAFT DELIVERY SYSTEM (MFR REPORT #2953200-2010-01379) BEYOND THE INTENDED LANDING ZONE, AND DURING ITS DEPLOYMENT, THE APEX OF THE STENT GRAFT OPENED MISALIGNED. ALTHOUGH THE PHYSICIAN PULLED THE DELIVERY SYSTEM BACKWARD, WHICH CORRECTED THE MISALIGNMENT, THE STENT GRAFT WAS INACCURATELY-PLACED NOT AT THE INTENDED LOCATION. THE MISALIGNED OPENING WAS DUE TO LARGE IN DIAMETER INNOMINATE ARTERY AND THE ASCENDING AORTIC ANEURYSM, WHICH PREVENTED THE APEX OF THE STENT GRAFT FROM APPOSING THE VESSEL WALL. THE SAME TYPE OF MISALIGNED OPENINGS AND INACCURATE PLACEMENT OCCURRED WITH TWO ADDITIONAL STENT GRAFTS (MFR REPORT #2953200-2010-01380; MFR. REPORT #2953200-2010-01381), AND THE THREE STENT GRAFTS WERE TELESCOPED INSIDE OF ONE ANOTHER. THE PHYSICIAN THEN ADVANCED AND STARTED THE DEPLOYMENT OF A FOURTH TALENT STENT GRAFT AT THE EXACT LANDING ZONE THAT THE DEVICE WAS TO BE PLACED; HOWEVER, THE DEVICE STILL LANDED SLIGHTLY LOWER THAN INTENDED. CONSEQUENTLY, THE PHYSICIAN IMPLANTED A FIFTH TALENT STENT GRAFT (MFR REPORT #2953200-2010-01383) PROXIMALLY, WHICH ALSO LANDED SLIGHTLY LOWER THEN INTENDED. THE PHYSICIAN THEN IMPLANTED ANOTHER TALENT STENT GRAFT SUCCESSFULLY AT THE INTENDED LANDING ZONE. 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 GALWAY NA V00471000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention