BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 6528161 · Received April 27, 2017

    Report

    Report Number
    2953200-2017-00693
    Event Type
    Injury
    Date Received
    April 27, 2017
    Date of Event
    March 17, 2009
    Report Date
    April 4, 2017
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; MID-TERM RESULTS OF THORACIC ENDOVASCULAR AORTIC REPAIR IN SURGICAL HIGH-RISK PATIENTS. VICTOR X. MOSQUERA, JOSE´ M. HERRERA, MILAGROS MARINI, FRANCISCO ESTEVEZ, IGNACIO CAO, DANIEL GUL´IAS, JOSE´ V. VALLE, JOSE´ J. CUENCA. INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY 9 (2009) 61¿65 TALENT AND VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR ENDOVASCULAR TREATMENT OF TYPE B DISSECTIONS, ATHEROSCLEROTIC ANEURYSMS, PENETRATING ULCERS, TRAUMATIC AORTIC RUPTURES. AND RUPTURED CRAWFORD TYPE I THORACOABDOMINAL ANEURYSM WITH MASSIVE LEFT HEMOTHORAX. ALL PATIENTS HAD BEEN CONSIDERED UNSUITABLE CANDIDATES FOR CONVENTIONAL OPEN SURGICAL REPAIR. THE FOLLOWING INFORMATION IS IN THIS JOURNAL ARTICLE: SEPTIC SHOCK CAUSED BY INTESTINAL ISCHEMIA, DEATH, TRANSIENT LEFT SUPERIOR LIMB MONOPARESIS, LEFT LOWER LIMB PARESIS WITH HYPALGESIA, CONGESTIVE HEART FAILURE, TYPE III SEPARATION ENDOLEAK. ABSTRACT BETWEEN MAY 2001 AND JUNE 2008, THE OUTCOME AND MORPHOLOGICAL CHANGES IN THORACIC AORTIC LESIONS OF 20 SURGICAL HIGH-RISK PATIENTS WHO UNDERWENT TEVAR WERE EVALUATED. AORTIC LESIONS INCLUDED 8 (40%) TYPE B DISSECTIONS, 5 (25%) ATHEROSCLEROTIC ANEURYSMS, 4 (20%) PENETRATING ULCERS AND 3 (15%) TRAUMATIC AORTIC RUPTURES. ALL PATIENTS WERE CLASSIFIED AS AMERICAN SOCIETY OF ANAESTHESIOLOGISTS CLASS IV AND OBTAINED HIGH SCORES IN BOTH THE LOGISTIC EUROPEAN SYSTEM FOR CARDIAC OPERATIVE RISK EVALUATION, MEDIAN OF 14.5% (RANGE 8.1¿65.7%), AND THE STS PARSONET 95 SCORING SYSTEM, MEDIAN OF 14 (RANGE 10¿52). ENDOVASCULAR STENT-GRAFT DEPLOYMENT WAS TECHNICALLY SUCCESSFUL IN ALL CASES. NO SURGICAL CONVERSION OCCURRED. EARLY MORTALITY WAS OBSERVED IN TWO PATIENTS. CLINICAL AND IMAGING FOLLOW-UP WAS AVAILABLE IN ALL PATIENTS AT A MEDIAN TIME OF 28 MONTHS (RANGE 4¿89 MONTHS). OVERALL ACTUARIAL SURVIVAL WAS 90% AT ONE AND FIVE YEARS AND 60% AT SEVEN YEARS. MEAN DIAMETER OF THE DESCENDING AORTA DECREASED FROM 51.1"13 MM TO 45.3"8 MM (PS0.032). MEAN REDUCTION IN DIMENSION OF ANEURYSMS WAS 10.7"8 MM. ENDOVASCULAR THORACIC AORTA REPAIR WILL PROBABLY BENEFIT MORE PATIENTS WITH MULTIPLE COMORBIDITIES THAT LIMIT THEIR LIFE EXPECTANCY THAN PATIENTS WITH A LOWER PROFILE. MEDICAL HISTORY: HYPERTENSION, "DISLIPEMIA," CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CORONARY ARTERY DISEASE, PERIPHERAL ARTERIOPATHY, PREVIOUS STROKE, CHRONIC RENAL FAILURE, PREVIOUS CARDIAC OR ABDOMINAL AORTIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306554 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention