BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 8568357 · Received May 1, 2019

    Report

    Report Number
    2953200-2019-00584
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    December 18, 2018
    Report Date
    May 1, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; COMPARISON OF CHIMNEY TECHNIQUE AND SINGLE-BRANCHED STENT GRAFT FOR TREATING PATIENTS WITH TYPE B AORTIC DISSECTIONS THAT INVOLVED THE LEFT SUBCLAVIAN ARTERY ZHANG, H., HUANG, H., ZHANG, Y. ET AL. CARDIOVASC INTERVENT RADIOL (2019) 42: 648. HTTPS://DOI.ORG/10.1007/S00270-018-2145-3. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF TYPE B AORTIC DISSECTIONS INVOLVING THE LEFT SUBCLAVIAN ARTERY ON UNKNOWN DATES. CHIMNEY TECHNIQUE WAS COMPLETED IN SOME PATIENTS. IT WAS REPORTED ON UNKNOWN DATES POST THE INDEX PROCEDURE THE FOLLOWING ADVERSE EVENTS WERE IDENTIFIED: UNKNOWN ENDOLEAK, ENDOGRAFT COMPRESSION, FALSE LUMEN PERFUSION. PER THE PHYSICIAN THE CAUSE OF THE EVENTS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363594 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR