BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA V12 COVERED STENT SYSTEM

    MDR report key: 9656994 · Received February 2, 2020

    Report

    Report Number
    3011175548-2020-00221
    Event Type
    Malfunction
    Date Received
    February 2, 2020
    Report Date
    February 2, 2020
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    NIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE INVESTIGATION WAS NOT ABLE TO BE PERFORMED AS NO PRODUCT CODE, LOT NUMBER OR SAMPLE WAS PROVIDED. THE ARTICLE CONCLUDED THAT THE USE OF HOMEMADE FENESTRATED STENT-GRAFTS FOR ENDOVASCULAR REPAIR OF AORTIC ARCH DISSECTIONS IS FEASIBLE AND EFFECTIVE FOR TOTAL ENDOVASCULAR AORTIC ARCH REPAIR. DURABILITY CONCERNS WILL NEED TO BE ASSESSED IN ADDITIONAL STUDIES WITH LONG-TERM FOLLOW-UP.

    Description of Event or Problem · 1

    RECEIVED AN ARTICLE TITLED: HOMEMADE FENESTRATED STENT GRAFTS FOR COMPLETE ENDOVASCULAR REPAIR OF AORTIC ARCH. PURPOSE: TO EVALUATE OUTCOMES OF HOMEMADE FENESTRATED STENT-GRAFTS FOR COMPLETE ENDOVASCULAR AORTIC REPAIR OF AORTIC ARCH DISSECTIONS. METHOD: FROM JULY 2014 THROUGH SEPTEMBER 2018, 35 PATIENTS UNDERWENT HOMEMADE FENESTRATED STENT-GRAFT REPAIR OF ACUTE OR CHRONIC COMPLICATED TYPE B AORTIC DISSECTIONS AND DISSECTING AORTIC ARCH ANEURYSMS SUBSEQUENT TO SURGICAL TREATMENT OF ACUTE TYPE A DISSECTIONS PROCEDURES WERE EMERGENT. PER THE ARTICLE ADVERSE EVENTS INCLUDED TYPE I ENDOLEAKS, ISCHEMIC EVENTS, TYPE II ENDOLEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120307 ADVANTA V12 COVERED STENT SYSTEM STENT, ILIAC NIO ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention