BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3907432 · Received July 1, 2014

    Report

    Report Number
    2953200-2014-01341
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    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. ABDOMINAL AORTIC ENDOGRAFTING BEYOND THE TRIALS: A 15-YEAR SINGLE-CENTER EXPERIENCE COMPARING NEWER TO OLDER GENERATION STENT-GRAFTS FABIO VERZINI, MD, PHD, FEBVS1; GIACOMO ISERNIA, MD1; PAOLA DE RANGO, MD, PHD, FEBVS1; GIOELE SIMONTE, MD1; GIANBATTISTA PARLANI, MD1; DILETTA LOSCHI, MD1; AND PIERGIORGIO CAO, MD, FRCS2 DOI: HTTP://DX.DOI.ORG/10.1583/13-4599MR.1. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: MIGRATION, OPEN CONVERSION, ENDOLEAK, OCCLUSION, GRAFT RUPTURE, THROMBUS, HEMORRHAGE, CARDIAC COMPLICATIONS, ISCHEMIA, PANCREATITIS PURPOSE: TO EVALUATE THE LATE RESULTS OF ENDOVASCULAR ANEURYSM REPAIR (EVAR) WITH THE ENDOGRAFTS CURRENTLY IN USE AND COMPARE OUTCOMES TO OLDER DEVICES. METHODS: CLINICAL, DEMOGRAPHIC, AND IMAGING DATA ON CONSECUTIVE PATIENTS UNDERGOING ELECTIVE EVAR FROM JANUARY 1997 TO DECEMBER 2011 AT A SINGLE CENTER WERE RETRIEVED FROM AN ELECTRONIC DATABASE AND REVIEWED. NEWER STENT-GRAFTS (NSG) WERE DEFINED AS THOSE INTRODUCED AFTER 2004 (SECOND-GENERATION EXCLUDER AND ANACONDA) OR CURRENTLY IN USE WITHOUT MODIFICATIONS (ZENITH, ENDURANT). OF THE 1412 CONSECUTIVE PATIENTS (1290 MEN; MEAN AGE 73 YEARS) WHO UNDERWENT ELECTIVE EVAR IN A TERTIARY UNIVERSITY HOSPITAL, 882 WERE TREATED WITH NSGS AND 530 WITH OLDER STENT-GRAFTS (OSGS). RESULTS: IN THE NSG GROUP, THE ABDOMINAL AORTIC ANEURYSMS (AAA) WERE LARGER (55.7 VS. 53.2 MM, P<(><<)>0.0001) AND THE PATIENTS WERE OLDER (P <(><<)>0.0001) AND LESS FREQUENTLY SMOKERS OR HAD PULMONARY DISEASE, WHILE HYPERTENSION AND DIABETES WERE MORE FREQUENT (ALL P<(> <<)>0.0001). THIRTY-DAY MORTALITY WAS 0.8% IN THE NSG GROUP VS. 1.1% IN THE OSG GROUP (P=NS). FOLLOW-UP RANGED FROM 1 TO 174 MONTHS (MEAN 54.1±42.4); THE OSG PATIENTS HAD LONGER MEAN FOLLOW-UP COMPARED TO THE NSG GROUP (80.2±47.9 VS. 38.4±29.1 MONTHS, P<(><<)>0.0001). ALL-CAUSE SURVIVAL RATES WERE COMPARABLE IN BOTH GROUPS. FREEDOM FROM LATE CONVERSION (96.1% VS. 89.1% AT 7 YEARS, P<(><<)>0.0001) OR REINTERVENTION (83.6% VS. 74.2% AT 7 YEARS, P=0.015) AND FREEDOM FROM AAA DIAMETER GROWTH >5 MM (P=0.022) WERE HIGHER IN THE NSG GROUP. IN ADJUSTED ANALYSES, THE USE OF A NEW-GENERATION DEVICE WAS A NEGATIVE INDEPENDENT PREDICTOR OF REINTERVENTION [HAZARD RATIO (HR) 0.67, 95% CONFIDENCE INTERVAL (CI) 0.49 TO 0.93, P=0.015] AND ANEURYSM GROWTH (HR 0.63, 95% CI 0.45 TO 0.89, P=0.010). CONCLUSION: NEWER-GENERATION ENDOGRAFTS CAN PERFORM SUBSTANTIALLY BETTER THAN THE OLDER DEVICES. IN THE LONG TERM, INCIDENCES OF REINTERVENTION, CONVERSION, AND AAA GROWTH ARE DECREASED IN PATIENTS TREATED WITH DEVICES CURRENTLY IN USE. HOWEVER, THE NEED FOR CONTINUOUS SURVEILLANCE IS STILL IMPERATIVE FOR ALL ENDOGRAFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384899 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention