BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT

    MDR report key: 3305717 · Received August 23, 2013

    Report

    Report Number
    2953200-2013-01637
    Event Type
    Death
    Date Received
    August 23, 2013
    Date of Event
    September 17, 2012
    Report Date
    July 31, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, MIGRATION, OCCLUSION, INFECTION, POST-OPERATIVE RUPTURE, DEATH); (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN). CONCLUSIONS: KNOWN INHERENT RISK OF A PROCEDURE (ENDOLEAK, MIGRATION, OCCLUSION, INFECTION, POST-OPERATIVE RUPTURE, DEATH); (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. EFFECT OF STENTGRAFT MODEL ON ANEURYSM SHRINKAGE IN 1,450 ENDOVASCULAR AORTIC REPAIRS. E. CIERI, P. DE RANGO, G. ISERNIA, G. SIMONTE, F. VERZINI, G. PARLANI, A. CIUCCI, P. CAO. EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, VOLUME 46 ISSUE 2: 192 ¿ 200. (B)(6). BACKGROUND: REGRESSION OF THE ANEURYSMAL SAC AFTER ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM (AAA) IS AN ACCEPTED INDICATOR OF ANEURYSM EXCLUSION. THIS STUDY EVALUATED THE SPONTANEOUS DECREASE IN SAC DIAMETER OVER A 10-YEAR PERIOD IN PATIENTS UNDERGOING ENDOVASCULAR ANEURYSM REPAIR (EVAR) WITH DIFFERENT STENT GRAFTS. METHODS: 1,450 PATIENTS (MEAN AGE 73.1 ± 7.7 YEARS; 1,325 MALE) UNDERGOING EVAR AND WITH A MINIMUM OF 1-YEAR COMPUTED TOMOGRAPHY (CT) IMAGING WERE INCLUDED. DIFFERENT IMPLANTED STENTGRAFTS (N = 622 [42.9%] ZENITH, N = 236 [16.3%] ANEURX, N = 179 [12.3%] TALENT, N = 83 [5.7%] ENDURANT, N = 236 [16.3%] EXCLUDER, N = 36 [2.5%] FORTRON, 53 [3.7%] ANACONDA, N = 5 [0.3%] OTHERS) WERE EMPLOYED. ¿PERSISTING SHRINKAGE¿ WAS MEASURED AS =5 MM AAA DIAMETER REGRESSION SPONTANEOUSLY PERSISTING OR INCREASING UNTIL THE END OF FOLLOW-UP WITHOUT REINTERVENTION. PERSISTING SHRINKAGE AMONG DEVICES WAS COMPARED WITH SURVIVAL AND COX REGRESSION ANALYSES. RESULTS: DURING A MEDIAN FOLLOW-UP OF 45 MONTHS (INTERQUARTILE RANGE, IQR, 21-79) PERSISTING SHRINKAGE WAS DETECTED IN 768 (53%) ANEURYSMS. KAPLANEMEIER ESTIMATES OF PERSISTING SHRINKAGE WERE 25.8% AT 1 YEAR, 63% AT 3 YEARS AND 72.6% AT 10 YEARS. PERSISTING SHRINKAGE RATES WERE SIGNIFICANTLY HIGHER FOR ZENITH (P <(><<)> .0001), ENDURANT (P = .013) AND NEW GENERATION EXCLUDER (P <(><<)> .0001) DEVICES. COX ANALYSES CONFIRMED THAT PERSISTING SHRINKAGE RATES WERE INDEPENDENTLY ASSOCIATED WITH ZENITH (OR 1.33; 95% CI: 1.176-1.514) AND ENDURANT (OR 1.52; 95% CI: 1.108-2.092) STENT GRAFTS AND NEGATIVELY ASSOCIATED WITH THE ANEURX (OR 0.57; 95% CI: 0.477-0.688) DEVICE. SURVIVAL RATES WERE HIGHER IN THE PERSISTING SHRINKAGE GROUP: 84.1% VS. 77.8% AT 3 YEARS, AND 53% VS. 38.1% AT 10 YEARS (P <(><<)> .0001). FREEDOM FROM AAA-RELATED-DEATH RATE WAS 100% AT 3 YEARS AND 99.7% AT 10 YEARS IN THE PERSISTING SHRINKAGE GROUP. CONCLUSIONS: ANEURYSM DIAMETER SHRINKAGE CAN BE ACHIEVED IN MOST CURRENT EVARS WITH PERSISTING EFFECT AT 10 YEARS FROM REPAIR AND INDICATES THE BENEFIT AND SAFETY OF TREATMENT. LAST GENERATION DEVICES SEEM TO BE IMPORTANT FACTORS IN INDUCING ANEURYSM SAC SHRINKAGE WITH SIMILAR CLINICALLY RELEVANT EFFECTS AMONG SINGLE MODELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410078 TALENT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Death| R