BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 7710369 · Received July 23, 2018

    Report

    Report Number
    2953200-2018-01086
    Event Type
    Injury
    Date Received
    July 23, 2018
    Date of Event
    May 1, 2018
    Report Date
    October 3, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; SURGICAL SITE AND GRAFT INFECTIONS IN ENDOVASCULAR AND OPEN ABDOMINAL AORTIC ANEURYSM SURGERY JASPER C.M. LANGENBERG, JAN A.J.W. KLUYTMANS, HANS G.W. DE GROOT, GWAN H. HO,1 EELCO J. VEEN, M.G. BUIMER AND LIJCKLE VAN DER LAAN SURGICAL INFECTIONS (2018) VOL 19, 4 DOI: 10.1089/SUR.2017.302. AGE/DATE OF BIRTH: AVERAGE AGE. SEX: AVERAGE GENDER. EXACT DATE OF IMPLANT 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 IN PATIENTS FOR THE ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSMS (AAA) BETWEEN JANUARY 2000 AND DECEMBER 2016. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: SURGICAL SITE AND STENT GRAFT INFECTIONS, REINTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552201 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention