BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 8815301 · Received July 23, 2019

    Report

    Report Number
    9612164-2019-03001
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    November 15, 2018
    Report Date
    July 23, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE DETAILS: TITLE: AORTIC REMODELING IN TYPE B AORTIC DISSECTION AFTER THORACIC ENDOVASCULAR AORTIC REPAIR WITH AN AORTIC EXTENDER CUFF IMPLANTATION AUTHORS: HONGGANG ZHANG, TONG QIAO CLINICAL INTERVENTIONS IN AGING, 2018: 13 2359-2366 DOI: HTTP://DX.DOI.ORG/10.2147/CIA.S179526. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED IN A PATIENT GROUP FOR THE ENDOVASCULAR REPAIR OF TYPE B AORTIC DISSECTIONS. ENDURANT AORTIC EXTENSION CUFFS WERE ALSO IMPLANTED DISTALLY IN SOME CASES, WITH NO OVERSIZING. THE CUFFS WERE PLACED FIRST IN THE TARGET POSITION, TO PROVIDE 30-40 MM OVERLAP WITH THE MAIN STENT GRAFTS. THE SIZE OF THE MAIN STENT GRAFT WAS CHOSEN ACCORDING TO THE MEASUREMENTS OF THE PROXIMAL NON-DISSECTED AORTA, WITH AN OVERSIZING OF 0¿15%. THE FOLLOWING MALFUNCTIONS WERE OBSERVED IN THE PATIENT GROUP: MALFUNCTIONS: UNKNOWN ENDOLEAK CUFF DISTORTION ENDOGRAFT COMPRESSION FALSE LUMEN PERFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609791 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR