BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 7316254 · Received March 6, 2018

    Report

    Report Number
    2953200-2018-00308
    Event Type
    Injury
    Date Received
    March 6, 2018
    Date of Event
    April 17, 2016
    Report Date
    March 5, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; THE SANDWICH TECHNIQUE WITH BODY FLOSSING WIRE TO REVASCULARIZE LEFT SUBCLAVIAN ARTERY IN THORACIC ENDOVASCULAR AORTIC REPAIR HUNG-LUNG HSU, CHEN-MING HUANG, YIN-YIN CHEN, FU-CHIEN HSIEH, AND JER-SHEN CHEN. (ANN VASC SURG 2017; 39: 152¿159) HTTP://DX.DOI.ORG/10.1016/J.AVSG.2016.04.016. (B)(4). FAILURE TO FOLLOW INSTRUCTIONS DUE TO USE OF OVERSIZED STENT GRAFT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC DISSECTION, PAU, THORACIC ANEURYSM REPAIR, OR TRAUMATIC AORTIC DISRUPTION, IN EITHER ZONE 1 OR ZONE 2. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE IA ENDOLEAK (WITH INTERVENTION), OCCLUSION WITHIN GRAFT, DISSECTION, PAU, AND TRAUMATIC AORTIC DISRUPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161384 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention