BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 11893750 · Received May 27, 2021

    Report

    Report Number
    9612164-2021-02093
    Event Type
    Death
    Date Received
    May 27, 2021
    Date of Event
    October 18, 2020
    Report Date
    May 27, 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 NOTIFICATION OF A LITERATURE ARTICLE ENTITLED; OUTCOMES OF ENDOVASCULAR STENT GRAFT REPAIR FOR PENETRATING AORTIC ULCERS WITH OR WITHOUT INTRAMURAL HEMATOMA XIAOLANG JIANG, MD, TIANYUE PAN, MD, LINGWEI ZOU, MD, BIN CHEN, MD, JUNHAO JIANG, MD, YUN SHI, MD, TAO MA, MD, CHANGPO LIN, MD, DAQIAO GUO, MD, XIN XU, MD, JUE YANG, MD, ZHENYU SHI, MD, TING ZHU, MD, ZHIHUI DONG, MD, AND WEIGUO FU, MD SOCIETY FOR VASCULAR SURGERY DOI: HTTPS://DOI.ORG/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 THORACIC STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR A TEVAR ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZED PAU WITH ASSOCIATED IMH ON AN UNKNOWN DATE. 60 MONTHS POST IMPLANT IT WAS REPORTED THE PATIENT EXPERIENCED SINE, IT WAS REPORTED THE PATIENT WAS ASYMPTOMATIC AND NO TREATMENT WAS PERFORMED 108 MONTHS POST INDEX IT WAS REPORTED THE PATIENT DIED SUDDENLY DURING FOLLOW-UP. THE EXACT CAUSE OF DEATH WAS UNKNOWN BECAUSE NO AUTOPSY WAS PERFORMED. HOWEVER, IT WAS ESTIMATED THAT RETROGRADE STANFORD TYPE A DISSECTION HAD DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794565 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death