BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 9641141 · Received January 29, 2020

    Report

    Report Number
    9612164-2020-00461
    Event Type
    Injury
    Date Received
    January 29, 2020
    Date of Event
    December 2, 2019
    Report Date
    January 29, 2020
    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

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED: OFF-THE-SHELF DEVICES FOR TREATMENT OF THORACIC AORTIC DISEASES: MIDTERM FOLLOW-UP OF TEVAR WITH CHIMNEYS OR PHYSICIAN-MADE FENESTRATIONS HTTPS://DOI.ORG/10.1177/1526602819890107 LEI ZHANG, MENG-TAO WU, GUANG-LANG ZHU, JIA-XUAN FENG, CHAO SONG, HAI-YAN LI, ZAI-PING JING, KAK KHEE YEUNG AND QING-SHENG LU JOURNAL OF ENDOVASCULAR THERAPY 2019 VOLUME 27 ISSUE 1. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THORACIC ENDOVASCULAR REPAIR OF AORTIC DISSECTIONS AND AORTIC ANEURYSMS. THE STE NT GRAFTS WERE CUSTOMISED INTO FENESTRATED STENT GRAFTS OR IMPLANTED AS PART OF A CHIMNEY PROCEDURE. THE FOLLOWING EVENTS WERE REPORTED: SERIOUS INJURY: RE-INTERVENTION RETROGRADE DISSECTION CEREBRAL INFARCTION MYOCARDIAL INFARCTION CEREBRAL ISCHEMIA (STROKE) TRANSIENT ISCHEMIC ATTACK PULMONARY INFECTION PARAPLEGIA OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105015 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention