BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA V12 VASCULAR STENTS

    MDR report key: 7921912 · Received October 1, 2018

    Report

    Report Number
    3011175548-2018-01073
    Event Type
    Injury
    Date Received
    October 1, 2018
    Report Date
    October 1, 2018
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    NIO
    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 THAT THE ENDOVASCULAR REPAIR OF TAAA BY USING COOK ZENITH FENESTRATED/BRANCHED ENDOGRAFTS IS FEASIBLE WITH ACCEPTABLE TECHNICAL AND CLINICAL RESULTS AT EARLY TO MID-TERM RESULTS IN PATIENTS AT HIGH SURGICAL RISK UNFIT FOR OR.

    Description of Event or Problem · 1

    ARTICLE RECEIVED: GALLITTO, E. E. (2017). ENDOVASCULAR REPAIR OF THORACOABDOMINAL AORTIC ANEURYSM IN HIGH SURGICAL RISK PATIENTS: FENESTRATED AND BRANCHED PATIENTS. ANNALS OF VASCULAR SURGERY, 170-177. PURPOSE:TO REPORT EARLY AND MID-TERM RESULTS OF ENDOVASCULAR REPAIR OF THORACOABDOMINAL AORTIC ANEURYSMS (TAAA) BY USING COOK ZENITH FENESTRATED/BRANCHED ENDOGRAFTES (FB-EVAR) IN HIGH SURGICAL RISK PATIENTS UNFIT FOR OPEN REPAIR. PER THE ARTICLE ADVERSE EVENTS INCLUDED: ILIAC RUPTURE, BLOOD LOSS REQUIRING TRANSFUSION, SPINAL CORD ISCHEMIA, ENDOLEAKS, CARDIAC AND PULMONARY COMPLICATIONS, RENAL OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762619 ADVANTA V12 VASCULAR STENTS STENT, ILLIAC NIO ATRIUM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention