BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA

    MDR report key: 4221802 · Received November 3, 2014

    Report

    Report Number
    2953200-2014-02289
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    January 1, 2014
    Report Date
    October 10, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. TYPE II ENDOLEAK IS AN ENIGMATIC AND UNPREDICTABLE MARKER OF WORSE OUTCOME AFTER ENDOVASCULAR ANEURYSM REPAIR. ENRICO CIERI, PAOLA DE RANGO, GIACOMO ISERNIA, GIOELE SIMONTE, ANDREA CIUCCI, GIANBATTISTA PARLANI, FABIO VERZINI, PIERGIORGIO CAO HTTP://DX.DOI.ORG/10.1016/J.JVS.2013.10.092 THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: ENDOLEAK, MIGRATION, STENT FRACTURE, ANEURYSM RUPTURE, SURGICAL CONVERSION, ANEURYSM ENLARGEMENT ENDURANT, TALENT AAA AND ANEURX STENT GRAFT SYSTEMS WERE IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. BACKGROUND: THIS STUDY ANALYZED PREDICTORS AND THE LONG-TERM CONSEQUENCE OF TYPE II ENDOLEAK IN A LARGE SERIES OF ELECTIVE ENDOVASCULAR ABDOMINAL ANEURYSM REPAIRS (EVARS). METHODS: BASELINE CHARACTERISTICS AND OPERATIVE AND FOLLOW-UP DATA OF CONSECUTIVE PATIENTS UNDERGOING EVAR WERE PROSPECTIVELY COLLECTED. PATIENTS WHO DEVELOPED TYPE II ENDOLEAK ACCORDING TO COMPUTED TOMOGRAPHY ANGIOGRAPHY AND THOSE WITHOUT TYPE II ENDOLEAK WERE COMPARED FOR BASELINE CHARACTERISTICS, MORTALITY, REINTERVENTION, CONVERSION, AND ANEURYSM GROWTH AFTER REPAIR. RESULTS: IN 1997-2011, 1412 CONSECUTIVE PATIENTS (91.4% MALES; MEAN AGE, 72.9 YEARS) UNDERWENT ELECTIVE EVAR AND WERE SUBSEQUENTLY FOLLOWED UP FOR A MEDIAN OF 45 MONTHS (INTERQUARTILE RANGE, 21-79 MONTHS). TYPE II ENDOLEAK DEVELOPED IN 218. ADJUSTED ANALYSIS FAILED TO IDENTIFY SIGNIFICANT INDEPENDENT PREDICTORS FOR TYPE II ENDOLEAK WITH THE EXCEPTION OF AGE (ODDS RATIO, 1.03; 95% CONFIDENCE INTERVAL, 1.01-1.05; P [.003) AND INTRALUMINAL THROMBUS (ODDS RATIO, 0.69; 95% CONFIDENCE INTERVAL, 0.53-0.92; P [ .010). TYPE II ENDOLEAK RATES WERE COMPARABLE REGARDLESS OF THE DEVICE MODEL. LATE ANEURYSM-RELATED SURVIVAL WAS PREDICTOR OF ANEURYSM GROWTH ALONG WITH AGE AND CARDIAC DISEASE. THE PRESENCE OF TYPE II ENDOLEAK LED TO REINTERVENTIONS IN 40% OF PATIENTS AND CONVERSION TO OPEN SURGERY IN 8%. HOWEVER, ASSESSMENT OF THESE PATIENTS AFTER REINTERVENTION SHOWED SIMILAR 60-MONTH FREEDOM RATES OF PERSISTING TYPE II ENDOLEAK (PRESENT IN MORE THAN TWO AFTER COMPUTED TOMOGRAPHY ANGIOGRAPHY SCAN STUDIES) AMONG THOSE WITH AND WITHOUT REINTERVENTIONS (49.8% VS 45.6%; P [ .639). ANEURYSM GROWTH >5 MM PERSISTED WITH COMPARABLE RATES IN TYPE II ENDOLEAK PATIENTS AFTER REINTERVENTION AND IN THOSE WHO REMAINED UNTREATED (42.9% VS 57.4% AT 60 MONTHS; P [ .117). CONCLUSIONS: REINTERVENTION FOR TYPE II ENDOLEAK WAS COMMON IN OUR PRACTICE, YET SUCH INTERVENTION DID NOT RELIABLY PREVENT THE CONTINUED EXPANSION OF THE ABDOMINAL AORTIC ANEURYSM. OUR DATA INDICATE TYPE II ENDOLEAK APPEARS TO BE A MARKER OF EVAR FAILURE THAT IS DIFFICULT TO PREDICT AND TREAT EFFECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703718 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention