BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 10874678 · Received November 20, 2020

    Report

    Report Number
    9612164-2020-04522
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    September 8, 2020
    Report Date
    November 20, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: ENDOVASCULAR ASCENDING AORTIC REPAIR IN TYPE A DISSECTION: A SYSTEMATIC REVIEW AHMED, Y, HOUBEN, IB, FIGUEROA, CA, ET AL. . J CARD SURG. 2020; 1¿ 12. HTTPS://DOI.ORG/10.1111/JOCS.15192 AMONG THE ENTIRE COHORT ALL-CAUSE MORTALITY RATE WAS 9%. THERE WAS NO INFORMATION TO SUGGEST ANY OF MEDTRONIC DEVICE FAILURES CAUSED OR CONTRIBUTED TO THE DEATHS, MEAN AGE, MEAN GENDER, 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 STENT GRAFT SYSTEMS WERE IMPLANTED IN CONJUNCTION WITH NON MDT STENT GRAFT SYSTEMS IN PATIENTS WITH TYPE A AORTIC DISSECTION (TAAD) UNDERGOING TEVAR ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: UNKNOWN ENDOLEAKS. THE CAUSE OF THE ADVERSE EVENTS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343445 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR