BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT AAA

    MDR report key: 3728327 · Received April 4, 2014

    Report

    Report Number
    2953200-2014-00653
    Event Type
    Death
    Date Received
    April 4, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 10, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. OPEN AORTIC REPAIR AFTER PRIOR THORACIC ENDOVASCULAR AORTIC REPAIR ERIC E. ROSELLI, MD, MOHAMED ABDEL-HALIM, MD, PHD, DOUGLAS R. JOHNSTON, MD, EDWARD G. SOLTESZ, MD, MPH, ROY K. GREENBERG, MD, LARS G. SVENSSON, MD, PHD, AND JOSEPH F. SABIK, III, MD (ANN THORAC SURG 2014;97:750¿7) HTTP://DX.DOI.ORG/10.1016/J.ATHORACSUR.2013.11.004 THE FOLLOWING ADVERSE EVENTS WERE REPORTED: DEATH, INFECTION, STENT GRAFT MIGRATION, ENDOLEAK, AORTIC DISSECTION, ANEURYSM RUPTURE, RESPIRATORY FAILURE, RENAL FAILURE, MYOCARDIAL INFARCTION. BACKGROUND. THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) HAS BEEN APPLIED TO INCREASINGLY COMPLEX AORTIC PATHOLOGY, RESULTING IN AN INCREASE IN LATE COMPLICATIONS. WE CHARACTERIZED PATIENTS UNDERGOING OPEN REPAIR AFTER PRIOR TEVAR INCLUDING INDICATIONS, OPERATIVE TECHNIQUES, AND OUTCOMES. METHODS. CHART REVIEW AND QUERY OF A PROSPECTIVELY COLLECTED DATABASE IDENTIFIED 50 PATIENTS WHO UNDERWENT THORACIC AORTIC OPERATION AFTER PRIOR TEVAR. ACTIVE FOLLOW-UP WAS SUPPLEMENTED BY SOCIAL SECURITY INFORMATION FOR VITAL STATUS. RESULTS. FROM JULY 2001 TO JANUARY 2012 OPEN ARCH (N [ 25), DESCENDING (N [ 6), THORACOABDOMINAL (N [ 17), OR EXTRA-ANATOMIC BYPASS (N [ 2) OPERATIONS WERE PERFORMED AFTER PREVIOUS TEVAR (MEDIAN INTERVAL FROM TEVAR TO OPEN SURGICAL PROCEDURE: 13.9 MONTHS; INTERQUARTILE RANGE, 0.5 TO 24 MONTHS). INDICATIONS FOR OPEN OPERATION INCLUDED TYPE 1 ENDOLEAKS (N [ 19), RETROGRADE AORTIC DISSECTION (N [ 9), CHRONIC AORTIC DISSECTION WITH PERSISTENT GROWTH OF THE FALSE LUMEN (N [ 16), AND GRAFT INFECTION (N [ 6). SIXTY 18% WERE DONE AS EMERGENCIES. CIRCULATORY SUPPORT WAS REQUIRED IN 78% AND HYPOTHERMIC ARREST IN 48%. HOSPITAL MORTALITY OCCURRED IN 3 (6%) PATIENTS WITH NO STROKES AND 1 PATIENT WITH MYO CARDIAL INFARCTION; 5 (10%) PATIENTS REQUIRED TRACHEOSTOMY AND 1 REQUIRED DIALYSIS. SURVIVAL WAS 67% AT A MEDIAN FOLLOW-UP OF 2.9 YEARS. CONCLUSIONS. CONVERSION TO OPEN REPAIR AFTER THORACIC STENT-GRAFTING MAY BE INDICATED FOR TYPE 1 ENDOLEAK, RETROGRADE DISSECTION, CHRONIC AORTIC DISSECTION WITH PERSISTENT FALSE LUMEN GROWTH, OR GRAFT INFECTION. THESE SALVAGE OPERATIONS ARE COMPLEX BUT CAN BE COMPLETED SAFELY WITH GOOD EARLY OUTCOMES AND PRESERVATION OF THE STENT-GRAFT IN MOST CASES. LATE OUTCOMES ARE CONSISTENT WITH THE CHRONIC DISEASE STATE OF THESE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204290 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Death