BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 10394969 · Received August 12, 2020

    Report

    Report Number
    9612164-2020-02960
    Event Type
    Injury
    Date Received
    August 12, 2020
    Date of Event
    June 9, 2020
    Report Date
    August 12, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; USE OF 3D PRINTING TO GUIDE CREATION OF FENESTRATIONS IN PHYSICIAN-MODIFIED STENT- GRAFTS FOR TREATMENT OF THORACOABDOMINAL AORTIC DISEASE TONG Y H , YU T, ZHOU M J, LIU C, ZHOU M,JIANG Q, LIU, J C, LI Q X <(>&<)> LIU Z. JOURNAL OF ENDOVASCULAR THERAPY 2020, VOL. 27(3) 385¿ 393 HTTPS://DOI.ORG/10.1177%2F1526602820917960. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT STENT GRAFTS AND NON-MDT STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF THORACOABDOMINAL AORTIC DISEASES IN 34 PATIENTS. ALL STENT GRAFTS WERE PHYSICIAN MODIFIED USING FENESTRATION TECHNIQUES. THE FOLLOWING MALFUNCTIONS WERE OBSERVED; UNKNOWN ENDOLEAK THE FOLLOWING ADVERSE EVENTS WERE OBSERVED; RUPTURE, CEREBRAL INFRACTION, DISSECTION A PATIENT DEATH WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT THE ENDURANT STENT GRAFT CAUSED OR CONTRIBUTED TO THIS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862942 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R