BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA

    MDR report key: 3217775 · Received July 10, 2013

    Report

    Report Number
    2953200-2013-01340
    Event Type
    Death
    Date Received
    July 10, 2013
    Date of Event
    October 26, 2012
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH, LEAK, MIGRATION, DISSECTION, OCCLUSION) PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVELY DISSECTED THORACIC AORTA AND PRE-OPERATIVE RUPTURED ANEURYSM); LACK OF INFORMATION (CAUSE IS UNKNOWN) CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVELY DISSECTED THORACIC AORTA AND PRE-OPERATIVE RUPTURED ANEURYSM); LACK OF INFORMATION (CAUSE IS UNKNOWN).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; AORTIC PATHOLOGY DETERMINES MIDTERM OUTCOME AFTER ENDOVASCULAR REPAIR OF THE THORACIC AORTA. BENJAMIN PATTERSON, BSC, MRCS; PETER HOLT, PHD, FRCS; CHRISOPH NIENABER, MD; RICHARD CAMBRIA, MD; RONALD FAIRMAN, MD; MATT THOMPSON, MD, FRCS. CARDIOVASCULAR SURGERY (CIRCULATION. 2013;127:24-32.) BACKGROUND¿ENDOVASCULAR REPAIR OF THE THORACIC AORTA HAS BECOME AN INCREASINGLY UTILIZED THERAPY. ALTHOUGH THE SHORT-TERM MORTALITY ADVANTAGE OVER OPEN SURGERY IS WELL DOCUMENTED, LATE MORTALITY AND THE IMPACT OF PRESENTING PATHOLOGY ON LONG-TERM OUTCOMES REMAIN POORLY REPORTED. METHODS AND RESULTS¿A DATABASE WAS BUILT FROM 5 PROSPECTIVE STUDIES AND A SINGLE INSTITUTIONAL SERIES. RATES OF PERIOPERATIVE ADVERSE EVENTS WERE CALCULATED, AS WERE MIDTERM DEATH AND REINTERVENTION RATES. MULTIVARIATE ANALYSIS WAS PERFORMED WITH THE USE OF LOGISTIC REGRESSION MODELING. KAPLAN-MEIER SURVIVAL CURVES WERE DRAWN FOR MIDTERM OUTCOMES. THE DATABASE CONTAINED 1010 PATIENTS: 670 PATIENTS WITH THORACIC AORTIC ANEURYSM, 195 WITH CHRONIC TYPE B AORTIC DISSECTION, AND 114 WITH ACUTE TYPE B AORTIC DISSECTION. LOWER ELECTIVE MORTALITY WAS OBSERVED IN PATIENTS WITH CHRONIC DISSECTIONS (3%) COMPARED WITH PATIENTS WITH ANEURYSMS (5%). MULTIVARIATE ANALYSIS IDENTIFIED AGE, MODE OF ADMISSION, AMERICAN SOCIETY OF ANESTHESIOLOGISTS GRADE, AND PATHOLOGY AS INDEPENDENT PREDICTORS OF 30-DAY DEATH (P <(><<)> 0.05). IN THE MIDTERM, THE ALL-CAUSE MORTALITY RATE WAS 8, 4.9, AND 3.2 DEATHS PER 100 PATIENT-YEARS FOR THORACIC AORTIC ANEURYSM, ACUTE TYPE B AORTIC DISSECTION, AND CHRONIC TYPE B AORTIC DISSECTION, RESPECTIVELY. THE RATES OF AORTIC-RELATED DEATH WERE 0.6, 1.2, AND 0.4 DEATHS PER 100 PATIENT-YEARS FOR THORACIC AORTIC ANEURYSM, ACUTE TYPE B AORTIC DISSECTION, ANDCHRONIC TYPE B AORTIC DISSECTION, RESPECTIVELY. CONCLUSIONS¿THIS STUDY INDICATED THAT THE MIDTERM OUTCOMES OF ENDOVASCULAR REPAIR OF THE THORACIC AORTA ARE DEFINED BY PRESENTING PA THOLOGY, ASSOCIATED COMORBIDITIES, AND MODE OF ADMISSION. NONAORTIC MORTALITY IS HIGH IN THE MIDTERM FOR PATIENTS WITH THORACIC AORTIC ANEURYSM, AND MANAGING MODIFIABLE RISK FACTORS APPEARS VITAL. ENDOVASCULAR REPAIR OF THE THORACIC AORTA RESULTS IN EXCELLENT MIDTERM PROTECTION FROM AORTIC-RELATED MORTALITY, REGARDLESS OF PRESENTING PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315510 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Death