BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3669211 · Received March 9, 2014

    Report

    Report Number
    2953200-2014-00436
    Event Type
    Death
    Date Received
    March 9, 2014
    Date of Event
    May 30, 2013
    Report Date
    February 11, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. IMPROVED RESULTS REFLECT DEVICE EVOLUTION AND REFINED PATIENT SELECTION. RAMI O. TADROS, PETER L. FARIES, SHARIF H. ELLOZY, RACHEL SCHRIER, SUNG YUP KIM, RAJESH MALIK, AGELIKI G. VOUYOUKA, ROBERT A. LOOKSTEIN, MICHAEL L. MARIN. VASCULAR SURGERY, THE MOUNT SINAI MEDICAL CENTER, NEW YORK, NY; JOURNAL OF VASCULAR SURGERY, (MAY 2013) VOL. 57, NO. 5, SUPP. SUPPL. 1, PP. 44S THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: BLOOD LOSS, PROCEDURAL RELATED DEATH, TYPE I ENDOLEAK, TYPE III ENDOLEAK, REINTERVENTION, DEATH, PERI-OPERATIVE COMPLICATION. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. OBJECTIVES: THERE HAVE BEEN THREE ERAS IN THE DEVELOPMENT OF EVAR: PHYSICIAN-MADE AND EARLY INDUSTRY DEVICES, INTERMEDIARY COMMERCIAL ENDOGRAFTS, AND MODERN STENT GRAFTS. THIS STUDY ANALYZED THE DIFFERENCES IN OUTCOMES BETWEEN THESE THREE GROUPS. METHODS: FROM 1992-2012, 1290 PATIENTS UNDERWENT ELECTIVE EVAR. FIFTEEN DIFFERENT DEVICES WERE USED DURING THIS TIME. THE THREE ERAS WERE DEFINED AS: ERA1: 1992-96; ERA2: 1997-2006; ERA3: 2007-2012. GRAFTS USED IN EACH ERA WERE: ERA1: PHYSICIAN-MADE AND EVT; ERA2: TALENT, ANEURX, EXCLUDER, QUANTUM LP, ZENITH, VANGAURD, PG AAA, ANCURE, ENDOLOGIX, AND TERAMED; ERA3: TALENT, ANEURX, ENDURANT, EXCLUDER, ZENITH, AND APTUS. RESULTS: MEAN AGE WAS 75.2 YEARS AND 85% WERE MEN. FIRST GENERATION PATIENTS WERE HIGHER SURGICAL RISK (MEAN GLASGOW ANEURYSM SCORES: ERA1 84.81 VS ERA3: 79.95, P= .048). ADJUNCTIVE PROCEDURES INCREASED FROM ERA1 TO ERA3 (P= .014). PROCEDURE TIMES (P <(><<)> .001), BLOOD LOSS (P= .01), AND LENGTH OF STAY (P <(><<)> .001) HAVE DECLINED OVERTIME. MAJOR PERI-OPERATIVE COMPLICATIONS (ERA1: 23%, ERA2: 9.2%, AND ERA3: 4.5%; P <(><<)> .001) AND AAA-RELATED PERI-OPERATIVE MORTALITY (ERA1: 17.6%, ERA2: 2.3%, AND ERA3: 0.0%; P <(><<)> .001) HAVE DECREASED. TYPE 1 AND 3 ENDOLEAKS (P= .011) AND THE NEED FOR REINTERVENTION (P <(><<)> .001) HAVE DIMINISHED. MEDIAN SURVIVAL FOR ALL CAUSES OF DEATH AND FREEDOM FROM ANEURYSM-RELATED MORTALITY SIGNIFICANTLY IMPROVED (FIG). CONCLUSIONS: EVAR HAS EVOLVED OVER THE LAST 20 YEARS RESULTING IN AN OVERALL IMPROVEMENT IN EFFICIENCY, OUTCOMES AND PROCEDURAL SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141867 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death| R