BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3638289 · Received February 20, 2014

    Report

    Report Number
    2953200-2014-00308
    Event Type
    Death
    Date Received
    February 20, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 27, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DATE OF DEATH IS UNKNOWN. (B)(4). RESULTS: UNSPECIFIED AORTIC NECK AND ILIAC ANATOMIC CHARACTERISTICS. ENDOLEAKS, ANEURYSM ENLARGEMENT, STENT GRAFT INFECTION, STENT GRAFT EXPLANT, STENT GRAFT OCCLUSION, VESSEL OCCLUSION, POST-OPERATIVE AORTIC RUPTURE, SEPSIS, AND DEATH. INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN. CONCLUSIONS: UNSPECIFIED AORTIC NECK AND ILIAC ANATOMIC CHARACTERISTICS. ENDOLEAKS, ANEURYSM ENLARGEMENT, STENT GRAFT INFECTION, STENT GRAFT EXPLANT, STENT GRAFT OCCLUSION, VESSEL OCCLUSION, POST-OPERATIVE AORTIC RUPTURE, SEPSIS, AND DEATH. INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. RESULTS OF ENDOVASCULAR REPAIR OF INFRARENAL AORTIC ANEURYSMS USING THE ENDURANT STENT GRAFT. ZANDVOORT HJ, GONÇALVES FB, VERHAGEN HJ, WERSON DA, MOLL FL, DE VRIES JP, VAN HERWAARDEN JA. (J VASC SURG 2014). DOI: 10.1016/J.JVS.2013.12.031. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: ENDOLEAKS, ANEURYSM ENLARGEMENT, STENT GRAFT INFECTION, STENT GRAFT EXPLANT, STENT GRAFT OCCLUSION, VESSEL OCCLUSION, POST-OPERATIVE AORTIC RUPTURE, SEPSIS, AND DEATH. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. OBJECTIVE: RECENT REPORTS SHOWED THAT THE ENDURANT STENT GRAFT (MEDTRONIC CARDIOVASCULAR, SANTA ROSA, CALIF) IS SAFE AND EFFECTIVE FOR ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS (AAAS). HOWEVER, DUE TO ITS RELATIVELY RECENT INTRODUCTION, ONLY SHORT-TERM FOLLOW-UP DATA ARE AVAILABLE. THIS STUDY PRESENTS THE 4-YEAR RESULTS USING THIS DEVICE. METHODS: ALL CLINICAL DATA, INCLUDING DETAILED ANATOMIC INFORMATION OF THE FIRST 100 CONSECUTIVE PATIENTS TREATED WITH THE ENDURANT STENT GRAFT FOR AN INFRARENAL AAA IN THREE DUTCH HIGH-VOLUME HOSPITALS, WERE PROSPECTIVELY COLLECTED. COMPUTED TOMOGRAPHY ANGIOGRAPHY WAS ROUTINELY PERFORMED BEFORE THE PROCEDURE, =1 MONTH, AND AT 1 YEAR POST-ENDOVASCULAR ANEURYSM REPAIR. THEREAFTER, THE IMAGING MODALITY DURING YEARLY FOLLOW-UP WAS INDIVIDUALIZED (DUPLEX ULTRASOUND IMAGING OR COMPUTED TOMOGRAPHY ANGIOGRAPHY). PATIENTS WERE CLASSIFIED AS WITHIN OR OUTSIDE THE INSTRUCTIONS FOR USE (IFU) FOR ANALYSIS. STUDY END POINTS WERE PRIMARY CLINICAL SUCCESS, OVERALL AND AAA-RELATED MORTALITY, AND SAC MORPHOLOGY CHANGES AND ENDOLEAK DURING FOLLOW-UP. ESTIMATES WERE OBTAINED USING KAPLAN-MEIER PLOTS. RESULTS: THE STUDY INCLUDED 100 CONSECUTIVE PATIENTS (88 MEN) WITH A MEDIAN AGE OF 74 YEARS (INTERQUARTILE RANGE [IQR], 67-79 YEARS) AND MEDIAN AAA DIAMETER OF 58 MM (IQR, 55-65 MM), BETWEEN DECEMBER 2007 AND MARCH 2009. TWENTY PATIENTS (20%) WERE TREATED OUTSIDE THE IFU (18, OUTSIDE PROXIMAL NECK IFU, ONE OUTSIDE ILIAC IFU, AND ONE OUTSIDE BOTH IFUS). MEDIAN FOLLOW-UP WAS 48 MONTHS (IQR, 36-53 MONTHS), AND NO PATIENTS WERE LOST. ONE CONTAINED RUPTURE WAS OBSERVED AFTER 1.5 MONTHS DUE TO GRAFT INFECTION. NO PATIENTS HAD GRAFT MIGRATION. TWO TYPE IA ENDOLEAKS, 5 TYPE IB ENDOLEAKS, AND 15 TYPE II ENDOLEAKS WERE FOUND. PRIMARY CLINICAL SUCCESS WAS 97%, 90%, 84% AND 77% AT 1, 2, 3, AND 4 YEARS, RESPECTIVELY. PRIMARY CLINICAL SUCCESS WAS COMPARABLE FOR PATIENTS TREATED WITHIN OR OUTSIDE IFU (P = .20), ALTHOUGH BOTH PATIENTS OUTSIDE ILIAC IFU NEEDED A SECONDARY ILIAC INTERVENTION. OVER TIME, MAXIMUM ANEURYSM DIAMETER DECREASED =5 MM, REMAINED STABLE, AND INCREASED =5 MM IN 58%, 32%, AND 10% OF THE PATIENTS, RESPECTIVELY. ALL-CAUSE MORTALITY WAS 20% AT 4 YEARS, WITH A 3% AAA-RELATED MORTALITY. CONCLUSIONS: THE 4-YEAR FOLLOW-UP DATA OF THE ENDURANT STENT GRAFT FOR AAA TREATMENT SHOWS ITS USE RESULTS IN A LOW AAA-RELATED MORTALITY WITH ADEQUATE PREVENTION OF RUPTURE OR ANEURYSM GROWTH. ALTHOUGH PATIENTS WITH VERY CHALLENGING ANATOMY WERE TREATED IN OUR SERIES, PRIMARY CLINICAL SUCCESS RATES WERE COMPARABLE FOR PATIENTS TREATED WITHIN AND OUTSIDE THE IFU. HOWEVER, BOTH PATIENTS OUTSIDE THE ILIAC IFU NEEDED A SECONDARY ILIAC INTERVENTION. THE KNOWLEDGE OF THE PRESENT RESULTS MAY AID IN IMPROVING OUTCOMES IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107826 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death| R