BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 11855473 · Received May 20, 2021

    Report

    Report Number
    9612164-2021-02000
    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
    P100040
    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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT AND NON MDT STENT GRAFT WERE IMPLANTED IN A PATIENT IN THE ENDOVASCULAR TREATMENT OF A PENETRATING AORTIC ULCER (PAU) AND INTRAMURAL HEMATOMA ON AN UNKNOWN DATE. IT WAS REPORTED 84 MONTHS LATER THE PATIENT HAD CHEST PAIN AND WAS DIAGNOSED WITH A DISTAL STENT-INDUCED NEW ENTRY (SINE) TEAR. THE PATIENT UNDERWENT ANOTHER TEVAR PROCEDURE. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756030 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other| R