BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 10874718 · Received November 20, 2020

    Report

    Report Number
    9612164-2020-04524
    Event Type
    Injury
    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
    Adverse Event
    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 A3: 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: STROKE, MI, RESPIRATORY FAILURE, AORTIC INSUFFICIENCY. THE CAUSE OF THE ADVERSE EVENTS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344313 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 Required Intervention