BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT (CT)

    MDR report key: 1884029 · Received October 14, 2010

    Report

    Report Number
    2953200-2010-01956
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    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). EVALUATION RESULTS: (HAD SECONDARY INTERVENTION FOR TREATED AAA), (CVA).

    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. THE PATIENT WAS TREATED FOR A SACCULAR THORACIC ANEURYSM AT ZONE 4. MAXIMUM ANEURYSM DIAMETER WAS 56MM AND THE LENGTH WAS 80MM. THE THORACIC AORTA IN THE PROXIMALLY WAS 34MM IN DIAMETER AND WAS 30 MM DISTALLY. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS MILDLY CALCIFIED COMMON ILIAC ARTERIES, AND MILD THROMBOSIS. IT WAS REPORTED THAT THERE WERE 2 TALENT STENT GRAFTS IMPLANTED (FIRST: TF3434 AND SECOND: TF3838). IT WAS REPORTED THAT AT THE SAME TIME THE PATIENT WAS TREATED FOR AN AAA BY ABDOMINAL SURGERY. THERE WERE NO ENDOLEAKS AT THE TIME OF IMPLANT. IT WAS REPORTED THAT THERE WAS AN ENDOLEAK BETWEEN BLOOD VESSEL PROSTHESIS AND STENT GRAFT IN THE ABDOMINAL. THE PATIENT'S ABDOMEN WAS RE-OPENED AND THE ENDOLEAK WAS TREATED. AFTER THE 2ND INTERVENTION, THE PATIENT REMAINED IN THE HOSPITAL. AT SOME TIME LATER, THE PATIENT HAD A CEREBELLA INFARCTION. THE PHYSICIAN COMMENT: CANNOT CONFIRM THE SERIOUSNESS OF THE CEREBELLAR INFARCTION, BECAUSE HE IS STILL ON THE BED DUE TO THE COMPLICATION. IT WAS LATER REPORTED THAT THE PATIENT'S CONDITION IS IMPROVING (REFERENCE MFR REPORT # 2953200-2010-01955).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT (CT) MIH MEDTRONIC CARDIOVASCULAR NA V00322252

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention