BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT - UNK

    MDR report key: 11854122 · Received May 20, 2021

    Report

    Report Number
    9612164-2021-01979
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    October 18, 2020
    Report Date
    May 20, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    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; OUTCOMES OF ENDOVASCULAR STENT GRAFT REPAIR FOR PENETRATING AORTIC ULCERS WITH OR WITHOUT INTRAMURAL HEMATOMA JIANG X, PAN T, ZOU L, CHEN B, JIANG J, SHI Y, MA T, LIN C, GUO D, XU X, YANG J, SHI Z, ZHU T, DONG Z, FU W JOURNAL OF VASCULAR SURGERY. 2021 MAY;73(5):1541-1548. DOI: 10.1016/J.JVS.2020.10.022 2. 4 PMA NUMBER ESTIMATED, PATIENTS IN THE STUDY UNDERWENT BOTH EVAR AND TEVAR PROCEDURES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT, TALENT & ENDURANT STENT GRAFTS AND NON MDT STENT GRAFTS WERE IMPLANTED IN PATIENTS IN THE ENDOVASCULAR TREATMENT OF PENETRATING AORTIC ULCERS. 42% OF THE PATIENT COHORT IN THE STUDY ALSO HAD INTRAMURAL HEMATOMAS . THE FOLLOWING MALFUNCTIONS WERE IDENTIFIED; TYPE IA, IB & UNKNOWN ENDOLEAKS, DIFFICULT TO POSITION THE FOLLOWING ADVERSE WERE IDENTIFIED; TEMPORARY PARAPLEGIA, STROKE, EMBOLISM, THROMBUS, RE-INTERVENTION PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754448 TALENT - UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND CV-SR-UNK-TALENT

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R