BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2080580 · Received April 22, 2011

    Report

    Report Number
    2953200-2011-00859
    Event Type
    Injury
    Date Received
    April 22, 2011
    Report Date
    March 23, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: (AORTIC DISSECTION), LACK OF INFO (ANEURYSM AND VESSEL MORPHOLOGY ARE UNK, UNK CAUSE OF DISSECTION). CONCLUSION: LACK OF INFO (ANEURYSM AND VESSEL MORPHOLOGY ARE UNK, UNK CAUSE OF DISSECTION).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM ON AN UNK DATE. ANEURYSM AND VESSEL MORPHOLOGY LEADING TO THIS EVENT WERE NOT REPORTED. IT WAS REPORTED THAT THE STENT GRAFT WAS EXPLANTED DUE TO A DISSECTION WHICH OCCURRED AT THE DISTAL PORTION OF THE STENT GRAFT. THE EXPLANTED STENT GRAFT WAS NOT RETURNED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS DOING 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 UNK Required Intervention