BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 12305971 · Received August 11, 2021

    Report

    Report Number
    9612164-2021-03076
    Event Type
    Injury
    Date Received
    August 11, 2021
    Date of Event
    May 25, 2017
    Report Date
    August 11, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; DELAYED TYPE III ENDOLEAK AFTER EVAR FOR ABNOMINAL ANEURYSM TAKUMA KOBAYASHI, MINORU MATSUHAMA, AND TOMOYUKI GOTO JPN J VASC SURG 2017; 26: 149¿152) DOI: 10.11401/JSVS.17-00023. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT MAIN BODY AND NON MDT LIMB WERE IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE ON AN UNKNOWN DATE. IT WAS REPORTED THAT ANEURYSM EXPANSION WAS IDENTIFIED 2 YEARS AFTER THE INDEX PROCEDURE, PREOPERATIVELY IT WAS THOUGHT THERE WAS A TYPE II ENDOLEAK BUT WHEN THE PATIENT WAS BROUGHT FOR INTERVENTION IT WAS FOUND THAT THERE WAS A TYPE IIIB ENDOLEAK IN THE MAIN BODY. IT WAS REPORTED THE STENT GRAFT WAS REPLACED. THE PATIENT SURVIVED THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206405 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention