BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA

    MDR report key: 4132912 · Received October 1, 2014

    Report

    Report Number
    2953200-2014-01962
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    October 12, 2012
    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
    MX
    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; ENDOVASCULAR TREATMENT OF TYPE B DISSECTION IN PATIENTS WITH MARFAN SYNDROME: MID-TERM OUTCOMES AND AORTIC ENDOVASCULAR ABDOMINAL. GUERING EID-LIDT, JORGE GASPAR,GABRIELA MELENDEZ-RAMIREZ, JORGE CERVANTES S, HECTOR GONZALEZ-PACHECO, FELIX DAMAS DE LOS SANTOS, ALOHA MEAVE-GONZALEZ, AND SAMUEL RAMIREZ MARROQUIN. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: HYPERTENSION, ISCHEMIA, RENAL FAILURE, POST-OPERATIVE RUPTURE, ENDOLEAK, SURGICAL CONVERSION. OBJECTIVES: TO EVALUATE THE MID-TERM OUTCOMES, AND THE AORTIC REMODELING IN MARFAN SYNDROME (MFS) PATIENTS WITH TYPE B DISSECTION THAT WERE TREATED WITH ENDOVASCULAR REPAIR. BACKGROUND: MFS IS A RELATIVE CONTRAINDICATION TO THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). MID-TERM AORTIC OUTCOMES DATA IN MFS AFTER TEVAR ARE LIMITED, AND THE OCCURRENCE OF LATE EVENTS REMAINS UNCLEAR. METHODS: OF 89 PATIENTS THAT UNDERWENT TEVAR BETWEEN SEPTEMBER 2002 AND FEBRUARY 2011, 10 PATIENTS WITH MID-TERM FOLLOW-UP FULFILLED THE GHENT CRITERIA FOR MFS AND COMPLICATED TYPE B DISSECTION. HIGH RISK FOR OPEN SURGERY WAS DOCUMENTED IN 90%. RESULTS: THE MEAN AGE WAS 35.1 6 9.4 YEARS AND ALL PATIENTS PRESENTED WITH ACUTE AORTIC SYNDROME COMPLICATING A CHRONIC TYPE B DISSECTION (DEBAKEY TYPE IIIB). FIVE PATIENTS UNDERWENT A BENTALL SURGICAL PROCEDURE PREVIOUS TO ENDOVASCULAR REPAIR, AND IN FOUR PATIENTS INITIAL TEVAR WAS FOLLOWED BY SURGERY OF THE ASCENDING AORTA. TREATMENT WAS LIMITED TO ENDOVASCULAR REPAIR IN ONLY ONE PATIENT. IN-HOSPITAL MORTALITY WAS 10%. AT A MEAN FOLLOW-UP OF 59.6 PLUS OR MINUS 38.9 MONTHS, THE CUMULATED MORTALITY WAS OF 20% AND LATE MORTALITY 11.1%. THE RATE OF SECONDARY ENDOLEAK WAS 44.4%, AND LATE RE-INTERVENTION OF 33.3%. SURVIVAL FREEDOM FROM CARDIOVASCULAR DEATH AT 8 YEARS WAS 80.0%, AND POSITIVE REMODELING WAS DOCUMENTED IN 37.5% OF PATIENTS. CONCLUSIONS: OUR RESULTS SUGGEST THAT TEVAR IS FEASIBLE, SAFE, AND ASSOCIATED WITH A HIGH RE-INTERVENTION RATE AND REDUCED RATE OF POSITIVE AORTIC REMODELING IN PATIENTS WITH MARFAN SYNDROME. SURVIVAL AT 8 YEARS WAS COMPARABLE TO CONTEMPORARY SERIES OF OPEN REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612337 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Required Intervention