BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 7713298 · Received July 24, 2018

    Report

    Report Number
    2953200-2018-01090
    Event Type
    Malfunction
    Date Received
    July 24, 2018
    Date of Event
    May 31, 2018
    Report Date
    October 3, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; OUTCOMES OVER TIME IN PATIENTS WITH HOSTILE NECK ANATOMY UNDERGOING ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM YOLANDA BRYCE, WONHO KIM, BARRY KATZEN, JAMES BENENATI & SHAUN SAMUELS J VASC INTERV RADIOL (2018) 29, HTTPS://DOI.ORG/10.1016/J.JVIR.2018.03.0. EXACT IMPLANT DATE UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT SENT GRAFT SYSTEMS WERE IMPLANTED INTO PATIENTS FOR THE ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM (AAA) ON DATES BETWEEN JANUARY 2004 AND DECEMBER 2013. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: TYPE IA ENDOLEAKS AND ANEURYSM ENLARGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558864 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR