BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 7942239 · Received October 8, 2018

    Report

    Report Number
    2953200-2018-01427
    Event Type
    Death
    Date Received
    October 8, 2018
    Date of Event
    July 2, 2018
    Report Date
    October 8, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; TEMPORAL AND MORPHOLOGICAL PATTERNS PREDICT OUTCOME OF ENDOVASCULAR REPAIR IN ACUTE COMPLICATED TYPE B AORTIC DISSECTION. CHRISTIAN SMEDBERG, REBECKA HULTGREN, MARTIN DELLE, LINUS BLOHMÉ, CHRISTIAN OLSSON, JOHNNY STEUER EUR J VASC ENDOVASC SURG (2018) 56, 349 - 355, DOI.ORG/10.1016/J.EJVS.2018.05.011. EXACT DATE OF DEATH UNKNOWN. EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT CAPTIVIA SENT GRAFT SYSTEMS WERE IMPLANTED INTO PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ACUTE OR SUBACUTE NON-TRAUMATIC TYPE B AORTIC DISSECTION ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784883 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death