BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 8507862 · Received April 12, 2019

    Report

    Report Number
    2953200-2019-00486
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 12, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; SHORT-TERM AND MIDTERM RESULTS OF FENESTRATED ANACONDA ENDOGRAFT IN PATIENTS WITH PREVIOUS ENDOVASCULAR ANEURYSM REPAIR ZAMIR ET AL, J VASC INTERV RADIOL 2019; 30:546¿553 HTTPS://DOI.ORG/10.1016/J.JVIR.2018.11.038. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS ON UNKNOWN DATES. 8 PATIENTS WERE FURTHER TREATED WITH FEVAR USING A NON MDT ENDOGRAFT FOR TYPE IA ENDOLEAKS IN THE ENDURANT STENT GRAFTS ON UNKNOWN DATES. IT WAS REPORTED ON A UNKNOWN DATE DURING FOLLOW UP, THE FOLLOWING ADVERSE EVENTS WERE REPORTED: INTERACTION WITH ANOTHER DEVICE AND A TYPE IB ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE EVENTS ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304445 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR