BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2950619 · Received February 8, 2013

    Report

    Report Number
    2953200-2013-00208
    Event Type
    Death
    Date Received
    February 8, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DEATH, ENDOLEAK. TORTUOUS, CALCIFIED ILIAC VESSELS, ANGULATED AND SHORT AORTIC NECK. STENT GRAFT WAS USED FOR TREATMENT OF PATIENTS WITH SHORT AORTIC NECKS. CONCLUSION: TORTUOUS, CALCIFIED ILIAC VESSELS, ANGULATED AND SHORT AORTIC NECK. STENT GRAFT WAS USED FOR TREATMENT OF PATIENTS WITH SHORT AORTIC NECKS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; NEW RESULTS IN THE ENDOVASCULAR MANAGEMENT OF ABDOMINAL AORTIC ANEURYSM (AAAS) (PART II); J CARDIOVASC SURG 2012; 53: 559-69. ENDURANT STENT GRAFTS WERE IMPLANTED. A NUMBER OF PUBLISHED STUDIES REFLECT THE AUTHORS ADVANCED EXPERIENCE WITH THIS ENDOPROSTHESIS. IN THE SUMMER OF 2010, THE AUTHORS PUBLISHED THE 2-YEAR RESULTS OF THIS PARTICULAR STENT-GRAFT SYSTEM IN 156 PATIENTS (67.9% OF THE PATIENTS HAD HOSTILE PROXIMAL NECK ANATOMY). ESTIMATED SURVIVAL, FREEDOM FROM TYPES I/ILL ENDOLEAK, FREEDOM FROM GRAFT THROMBOSIS, AND FREEDOM FROM ANY DEVICE-RELATED RE-INTERVENTIONS AT 2 YEARS WERE 94.7%, 96.9%, 97.8%, AND 92.6%, RESPECTIVELY. RECENTLY, WE PUBLISHED EARLY- AND INTERMEDIATE RESULTS IN PATIENTS TREATED ACCORDING TO DEVICE-SPECIFIC INSTRUCTIONS FOR USE FOR THE PROXIMAL AORTIC NECK COMPARED WITH PATIENTS TREATED IN AN OFF-LABEL (OL) SITUATION. BETWEEN NOVEMBER 2007 AND MARCH 2010, 177 CONSECUTIVE PATIENTS WITH AAAS WERE TREATED WITH THE ENDURANT STENT-GRAFT AT OUR INSTITUTION, REPRESENTING THE LARGEST SINGLE-CENTRE REPORT IN THE LITERATURE. THE FINDINGS OF OUR STUDY WERE THAT PATIENTS WITH NORMAL AND COMPLEX ANATOMY OF THE PROXIMAL AORTIC NECK HAVE ACCEPTABLE RESULTS, WITH NO SIGNIFICANT DIFFERENCE IN SURVIVAL, MAJOR ADVERSE MORBIDITY, OR RE-INTERVENTIONS. HOWEVER, A GREATER RISK OF TYPE I ENDOLEAK OCCURRED WHEN OFF-LABEL INDICATIONS WERE APPLIED. THE USE OF THIS FLEXIBLE DEVICE IN TORTUOUS AND SEVERE CALCIFIED ILIAC VESSELS AND ANGULATED OR SHORT NECK IS ALSO BENEFICIAL IN CASE OF SYMPTOMATIC ANEURYSMS REQUIRING URGENT TREATMENT. IN THIS CONTEXT, WE HAVE REPORTED OUR ADVANCED EXPERIENCE WITH THE USE OF THE ENDURANT ENDOGRAFT IN THE SO-CALLED CHIMNEY ENDOVASCULAR TECHNIQUE (TOTAL ENDOVASCULAR TREATMENT BY PLACING OF CHIMNEY GRAFTS INTO AORTIC SIDE BRANCHES WHICH ARE INVOLVED IN THE ANEURYSM OUTSIDE AND PARALLEL TO THE MAIN ABDOMINAL ENDOGRAFT). OUR LATEST REPORT IN COLLABORATION WITH THE ZURICH COLLEAGUES SHOWED EXCELLENT MID-TERM RESULTS AFTER USE OF THE TECHNIQUE FOR PARARENAL AORTIC PATHOLOGIES WITH EXCELLENT PATENCY AND LOW INCIDENCE OF ENDOLEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55102 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention