BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA

    MDR report key: 4132948 · Received October 1, 2014

    Report

    Report Number
    2953200-2014-01964
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    March 20, 2013
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE; DEPLOYMENT OF PROXIMAL THORACIC ENDOGRAFT IN ZONE 0 OF THE ASCENDING AORTA: TREATMENT OPTIONS AND EARLY OUTCOMES FOR AORTIC ARCH ANEURYSMS IN A HIGH-RISK POPULATION. OURANIA PREVENTZA, FAISAL G. BAKAEENA, ROBERTO D. CERVERAA AND JOSEPH S. COSELLIA. EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 44 (2013) 446¿453 THE FOLLOWING ADVERSE EVENTS WERE OBSERVED STROKE, PARAPARESIS, ATRIAL FIBRILLATION, TRACHEOSTOMY, BLEEDING, ENDOLEAK, AORTIC RE-INTERVENTION, ACUTE RENAL INSUFFICIENCY, DISSECTION. OBJECTIVES: OPEN REPAIR OF AORTIC ARCH ANEURYSMS CAN BE TECHNICALLY CHALLENGING. HYBRID APPROACHES HAVE BEEN DEVELOPED TO FACILITATE ARCH REPAIRS AND IMPROVE THEIR CLINICAL OUTCOMES IN HIGH-RISK PATIENTS. WE EXAMINED TREATMENT OPTIONS AND EARLY OUTCOMES IN PATIENTS WHOSE THORACIC ENDOGRAFTS WERE DEPLOYED TO INCLUDE ZONE 0. METHODS: BETWEEN 2005 AND 2011, A HYBRID APPROACH IN WHICH THE ENDOGRAFT WAS DEPLOYED IN THE ASCENDING AORTA WAS USED IN 29 PATIENTS (MEDIAN AGE 67 YEARS, RANGE 32¿85 YEARS). THE INDICATION FOR SURGERY WAS SACCULAR ARCH ANEURYSM IN 11 PATIENTS (37.9%), FUSIFORM ARCH ANEURYSM WITH OR WITHOUT INVOLVEMENT OF THE PROXIMAL DESCENDING AORTA IN 10 (34.5%), PROXIMAL TYPE I ENDOLEAK AFTER ENDOVASCULAR REPAIR OF THE DESCENDING AORTA IN 5 (17.2%), CHRONIC TYPE III (TYPE B) AORTIC DISSECTION WITH ANEURYSMAL ARCH FORMATION IN 2 (6.9%) AND ACUTE TYPE I (TYPE A) DISSECTION WITH PRIOR REPAIR OF AN EXTENT I THORACOABDOMINAL ANEURYSM IN 1 (3.4%). SIX PATIENTS (20.7%) HAD PREVIOUSLY UNDERGONE A STERNOTOMY. ONE-, TWO- OR THREE-BRANCH AORTOBRACHIOCEPHALIC DE-BRANCHING, WITH OR WITHOUT CONCOMITANT HEART SURGERY, WAS PERFORMED IN 28 PATIENTS AND EXTRA-ANATOMIC BYPASS IN 1. RESULTS: TWO PATIENTS (6.9%) DIED DURING POSTOPERATIVE HOSPITALIZATION. OVERALL SURVIVAL DURING THE FOLLOW-UP PERIOD (MEDIAN 411 DAYS) WAS 79.3%. FIVE NEUROLOGICAL EVENTS OCCURRED: ONE EXTENSIVE STROKE, TWO MINOR STROKES (10.3%) AND TWO EPISODES OF PARAPARESIS (6.9%), ONE WITH PARTIAL RECOVERY AND ONE WITH FULL RECOVERY. CONCLUSIONS: THE HYBRID APPROACH ENABLES THE TREATMENT OF AORTIC ARCH DISEASE IN HIGH-RISK INDIVIDUALS. LONG-TERM FOLLOW-UP DATA ARE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612365 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention