BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA V12 VASCULAR STENTS

    MDR report key: 7921953 · Received October 1, 2018

    Report

    Report Number
    3011175548-2018-01087
    Event Type
    Injury
    Date Received
    October 1, 2018
    Report Date
    October 1, 2018
    Manufacturer
    ATRIUM MEDICAL
    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. THE ARTICLE CONCLUDED THE FENESTRATED ANACONDA STENT GRAFT SYSTEM OFFERS ACCEPTABLE TECHNICAL SUCCESS RATES, MIDTERM EFFICACY AND DURABILITY WITH RESPECT TO ANEURYSM SAC REGRESSION, TARGET VESSEL PATENCY, OVERALL MORTALITY AND RE-INTERVENTION RATES.

    Description of Event or Problem · 1

    ARTICLE RECEIVED: MIDY, D. E. (2017). RESULTS OF THE FRENCH MULTICENTRIC STUDY OF ANACONDA FENESTRATED ENDOGRAFTS IN THE TREATMENT OF COMPLEX AORTIC PATHOLOGIES (EFEFA REGISTRY). ANNALS OF VASCULAR SURGERY, 151-165. PURPOSE: TO ASSESS THE MIDTERM RESULTS IN THE TREATMENT OF COMPLEX AORTIC ANEURYSMS. PER THE ARTICLE ADVERSE EVENTS INCLUDED ENDOLEAKS, OCCLUSION, ISCHEMIA, THROMBOSIS AND PSEUDOANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763288 ADVANTA V12 VASCULAR STENTS STENT, RENAL NIN ATRIUM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention