BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1101745 · Received August 7, 2008

    Report

    Report Number
    2953200-2008-00659
    Event Type
    Injury
    Date Received
    August 7, 2008
    Report Date
    July 16, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A CHRONIC EXPANDING TYPE B DISSECTION. THIS EVENT WAS REPORTED IN THE JOURNAL OF VASCULAR SURGERY 2008; 47: 1195-1202, JUNE 2008. THE STENT GRAFTS WERE IMPLANTED BETWEEN 2001 AND 2007. IT WAS REPORTED THE PATIENT RECEIVED A TALENT DEVICE TO TREAT A CHRONIC EXPANDING TYPE B DISSECTION AND A CONTAINED RUPTURE THAT DEVELOPED DUE TO A DISTAL TYPE 1 ENDOLEAK AND RE-PRESSURIZED FALSE LUMEN 10 DAYS POST PROCEDURE. THE DISTAL DESCENDING AORTA HAD ANEURYSMAL DISEASE THAT DID NOT ALLOW ENDOVASCULAR EXTENSION TO EXCLUDE THE ANEURYSM. THE PATIENT WAS TREATED BY AN EMERGENCY PROCEDURE INVOLVING REPLACEMENT OF THE DESCENDING THORACIC AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WAS DISCHARGED.

    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 43 YR Required Intervention