BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA V12 COVERED STENT

    MDR report key: 8308828 · Received February 5, 2019

    Report

    Report Number
    3011175548-2019-00139
    Event Type
    Injury
    Date Received
    February 5, 2019
    Report Date
    February 5, 2019
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    NIN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 STUDY CONCLUDED CH-EVAS IS AN OFF-THE-SHELF SOLUTION TO TREAT JAAS WITH HIGH TECHNICAL SUCCESS.

    Description of Event or Problem · 1

    RECEIVED AN ARTICLE TITLED CHIMNEY TECHNIQUE IN COMBINATION WITH A SAC-ANCHORING ENDOGRAFT FOR JUXTARENAL AORTIC ANEURYSMS: TECHNICAL ASPECTS AND EARLY RESULTS. THE ARTICLE PRESENTED TECHNICAL ASPECTS AND EARLY CLINICAL RESULTS OF A MULTICENTER EXPERIENCE WITH CH-EVAS. PER THE ARTICLE ADVERSE EVENTS INCLUDED: ISCHEMIC EVENTS, ARTERIAL INJURY, BLEEDING (HEMORRHAGE AND ENDOLEAKS), AND OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101746 ADVANTA V12 COVERED STENT STENT, RENAL NIN ATRIUM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention