BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT

    MDR report key: 7327269 · Received March 9, 2018

    Report

    Report Number
    2953200-2018-00355
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    October 25, 2017
    Report Date
    March 9, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; AORTIC BIFURCATION MORPHOLOGY ALONE IS NOT ABLE TO PREDICT OUTCOME IN PATIENTS SUBMITTED TO ELECTIVE ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR PASQUALINO SIRIGNANO, LAURA CAPOCCIA, CHIARA PRANTEDA, NUNZIO MONTELIONE, WASSIM MANSOUR, ALESSANDRO D¿ADAMO, MARTINA FORMICONI, F RANCESCO SPEZIALE DOI 10.1007/S00270-017-1831-X. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE IA,IB,II,IIIA ENDOLEAKS, OCCLUSION WITHIN THE DEVICE, DIFFICULT TO INSERT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169311 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR