BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA V12 COVERED STENT

    MDR report key: 6814969 · Received August 23, 2017

    Report

    Report Number
    3011175548-2017-00068
    Event Type
    Injury
    Date Received
    August 23, 2017
    Report Date
    August 17, 2017
    Manufacturer
    ATRIUM MEDICAL CORPROATION
    Product Code
    NIN
    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. QUESTIONS WERE SENT TO THE AUTHOR OF THE ARTICLE. NO RESPONSE WAS RECEIVED. THE STUDY CONCLUDED THAT C-EVAR IS FEASIBLE AND EFFICIENT TO TREAT JAA IN PATIENTS UNSUITABLE FOR FENESTRATED BRANCHED ENDOGRAFTS (FBE). ASSOCIATED FILES: 3011175548-2017-00062, 3011175548-2017-00063, 3011175548-2017-00064, 3011175548-2017-00065, 3011175548-2017-00066, 3011175548-2017-00067.

    Description of Event or Problem · 1

    RECEIVED AN ARTICLE TITLED: TECHNICAL ASPECTS, CURRENT INDICATIONS, AND RESULTS OF CHIMNEY GRAFTS FOR JUXTARENAL AORTIC ANEURYSMS PUBLISHED IN THE JOURNAL OF VASCULAR SURGERY. THE PURPOSE OF THIS ARTICLE WAS TO REPORT PRELIMINARY EXPERIENCE WITH CHIMNEY GRAFTS FOR JUXTARENAL AORTIC ANEURYSMS (JAA) IN AN EFFORT TO REVIEW ITS INDICATIONS IN THE ERA OF FENESTRATED BRANCHED ENDOGRAFTS. FROM 2000 TO 2010, 57 PATIENTS WITH ENDOVASCULAR REPAIR OF AORTIC ANEURYSMS WERE REVIEWED. 16 PATIENTS WITH C-EVAR PER THE ARTICLE, PROCEDURAL COMPLICATIONS INCLUDED ONE PATIENT WHO LEFT AGAINST MEDICAL ADVICE AND WITHOUT ANTI-PLATELET/ANTI-THROMBIN THERAPY. HE WAS READMITTED ON POST OF DAY 22 FOR MESENTERIC ISCHEMIA CAUSED BY MESENTERIC STENT THROMBOSIS. HE DIED FROM MULTI-ORGAN FAILURE AS A RESULT OF INTESTINAL ISCHEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595280 ADVANTA V12 COVERED STENT PTFE COVERED STENT NIN ATRIUM MEDICAL CORPROATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention