BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3648343 · Received February 26, 2014

    Report

    Report Number
    2953200-2014-00343
    Event Type
    Injury
    Date Received
    February 26, 2014
    Date of Event
    October 28, 2013
    Report Date
    January 31, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION), (CAUSE OF EVENT IS UNKNOWN); EVALUATION, CONCLUSION: INHERENT RISK OF A PROCEDURE (OCCLUSION), (CAUSE OF EVENT IS UNKNOWN).

    Description of Event or Problem · 1

    THE ¿OPEN¿ CHIMNEY GRAFT TECHNIQUE FOR JUXTARENAL AORTIC ANEURYSMS WITH DISCREPANT RENAL ARTERIES HTTP://DX.DOI.ORG/10.1016/J.EJVS.2013.10.022 AUTHORS: E. DUCASSE, S. LEPIDI, C. BROCHIER, S. DEGLISE, X. BERARD, D. ALBERTI, D. MIDY EVENTS REPORTED IN THIS ARTICLE: OCCLUSION, SNORKEL, OCCLUSION VESSEL COVERAGE. POST-OP NINE DAYS LEFT ENDOGRAFT LEG THROMBOSIS, THROMBECTOMY AND STENTING. THE ANEURYSM WAS 75 MM IN DIAMETER. INFRARENAL DIAMETER 15 MM BELOW THE LOWEST RENAL ARTERY WAS 46 MM IN DIAMETER. PROXIMAL LANDING ZONE WAS 21 MM IN DIAMETER. THE AORTIC ANGLE WAS 120 DEGREES. INFRARENAL NECK LENGTH WAS 6 MM IN DIAMETER. THE DIAMETER OF THE LOWEST RENAL ARTERY 6 MM. OBJECTIVES: A STRAIGHTFORWARD ORIGINAL CHIMNEY GRAFT (CG) PROTOCOL HAS BEEN DEVELOPED AT OUR INSTITUTION IN SELECTED CASES OF JUXTARENAL AORTIC ANEURYSM (JRAA). THE AIM OF THIS STUDY WAS TO PRESENT OUR CLINICAL EXPERIENCE OF CONSECUTIVE SERIES WITH USE OF UNCOVERED SELF-EXPANDING STENT (SES) AS ¿OPEN CHIMNEY¿ (OCH) IN THE ENDOVASCULAR REPAIR (EVAR) OF JRAA. METHODS: A STANDARD ENDOGRAFT WITH SUPRARENAL FIXATION STRUTS IS DELIVERED WITH ITS PROXIMAL COVERED EDGE JUST BELOW THE HIGHEST RA IN JRAA PRESENTING THE OSTIUM OF THE TWO RENAL ARTERIES AT A DIFFERENT AORTIC LEVEL AND THE DISTANCE BETWEEN THE HIGHEST RENAL ARTERY AND THE BEGINNING OF THE ANEURYSM (IMPROVED LANDING ZONE) 10 MM. THE LOW-LYING RENAL ARTERY IS MAINTAINED PATENT BY THE OCH GRAFT (STANDARD SES) DELIVERED FROM LEFT BRACHIAL ACCESS (6 FR). ALL CLINICAL, ANATOMICAL, AND OPERATIVE DATA WERE PROSPECTIVELY COLLECTED AND RETRIEVED FOR THE STUDY ANALYSIS. RESULTS: FROM (B)(6) 2010 TO (B)(6) 2012, OCH EVAR WAS OFFERED TO 22 CONSECUTIVE PATIENTS CONSIDERED UNFIT FOR JRAA OPEN REPAIR. ALL PROCEDURES WERE TECHNICALLY SUCCESSFUL WITH ANEURYSM EXCLUSION AND PATENT OCH GRAFT. ONE SMALL PERIOPERATIVE TYPE IA ENDOLEAK SPONTANEOUSLY DISAPPEARED AT THE 3-MONTH CT CONTROL. ONE PATIENT DIED BECAUSE OF ACUTE DECOMPENSATED HEART FAILURE. ONE PATIENT PRESENTED A LEFT HEMISPHERIC STROKE. THE MEDIAN FOLLOW-UP OF 18 MONTHS (RANGE 7E35) SHOWED ANEURYSM EXCLUSION IN ALL PATIENTS WITHOUT TYPE I AND III ENDOLEAKS, SES STENOSIS, AND/OR RENAL IMPAIRMENT. CONCLUSIONS: OCH-EVAR IS A STRAIGHTFORWARD TECHNIQUE THAT CAN BE EMPLOYED IN SELECTED CASES OF JRAA, AVOIDING THE MORE COMPLEX AND EXPENSIVE FENESTRATED EVAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118982 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention