BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVANTA V12 VASCULAR STENTS

    MDR report key: 7942818 · Received October 8, 2018

    Report

    Report Number
    3011175548-2018-01110
    Event Type
    Death
    Date Received
    October 8, 2018
    Report Date
    October 8, 2018
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    NIN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 ¿REAL WORLD¿ FEASIBILITY OF THE FENESTRATED ANACONDA STENT GRAFT IS DEMONSTRATED WITH 4% PERIOPERATIVE MORTALITY. LIMB THROMBOSIS DURING FOLLOW UP IS OF CONCERN.

    Description of Event or Problem · 1

    ARTICLE: SHAHVERDYAN, R. E. (2016). SINGLE CENTRE RESULTS OF TOTAL ENDOVASCULAR REPAIR OF COMPLEX AORTIC ANEURYSMS WITH CUSTOM MADE ANACONDA FENESTRATED STENT GRAFTS. EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, 500-508. PURPOSE: TO REPORT EXPERIENCE USING THE ANACONDA FENESTRATED DEVICE WITH SPECIAL EMPHASIS ON TARGET VESSEL PATENCY AND PITFALLS WITH THE DEVICE. PER THE ARTICLE DEATHS OCCURRED WITHIN THE STUDY PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786415 ADVANTA V12 VASCULAR STENTS STENT, RENAL NIN ATRIUM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death