BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 7840877 · Received September 3, 2018

    Report

    Report Number
    9612164-2018-02251
    Event Type
    Injury
    Date Received
    September 3, 2018
    Date of Event
    July 28, 2018
    Report Date
    September 3, 2018
    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

    TITLE: COMPUTATIONAL INVESTIGATION OF INTERACTION BETWEEN STENT GRAFT AND AORTA IN RETROGRADE TYPE A DISSECTION AFTER THORACIC ENDOVASCULAR AORTIC REPAIR FOR TYPE B AORTIC DISSECTION AUTHORS: TAO MA, MD,A ZHI HUI DONG, MD,A SHENGZHANG WANG, PHD,B ZHUANG YUAN MENG, BD,B YIN YIN CHEN, MD,C AND WEI GUO FU, MD, JOURNAL OF VASCULAR SURGERY (2018) 06.008 DOI.ORG/10.1016/J.JVS.2018.06.008. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A VALIANT OR A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN RTAD ON AN UNKNOWN DATE. IT WAS REPORTED THAT AT AN UNKNOWN DATE THE PATIENT DEVELOPED RETROGRADE TYPE A DISSECTION (RTAD) WITH PARTIALLY THROMBOSED FALSE LUMEN AND HAD OPEN REPAIR OF ASCENDING AORTA AND AORTIC ARCH. DURING THE PROCEDURE, THE NEW ENTRY WAS SEEN AT THE TIP OF THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681672 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention