BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2230694 · Received August 17, 2011

    Report

    Report Number
    2953200-2011-01452
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    March 23, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS, CONCLUSION: (IMPLANTATION OF THE DEVICE TO TREAT A PRE-OPERATIVE DISSECTION).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION ANEURYSM APPROX 19 MONTHS AGO. THE AORTA WAS DESCRIBED AS BEING FRAGILE. INITIALLY, ON AN UNK DATE, A HOMEMADE STENT GRAFT HAD BEEN IMPLANTED IN ZONE 3 VIA AN OPEN SURGICAL REPAIR, AND A STENT GRAFT FROM ANOTHER MFR WAS THEN IMPLANTED IN ZONE 4 FOR A CHRONIC TYPE B AORTIC DISSECTION. APPROX 5 MONTHS AGO, A THORACIC ANEURYSM WAS CONFIRMED DISTAL TO THE OTHER MFR'S STENT GRAFT. APPROX 1 MONTH AGO, THE PHYSICIAN ELECTED TO INTERVENE BY PLACING A SECOND STENT GRAFT FROM THE OTHER MFR FROM THE MIDDLE OF THE TALENT THORACIC STENT GRAFT THROUGH THE EXISTING DISTAL-MOST STENT GRAFT TO EXCLUDE THE NEW ANEURYSM SUCCESSFULLY. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention