BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 4202965 · Received October 27, 2014

    Report

    Report Number
    2953200-2014-02193
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 1, 2014
    Report Date
    March 2, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN DEPLOYED THE BIFURCATE IN A SHORT RENAL TO DISTAL AORTA LENGTH AORTA. THE CONTRALATERAL GATE "JAILED OFF" IN THE RIGHT ILIAC ARTERY AND WOULDN'T OPEN. CANNULATION AND SNARE ATTEMPTS WERE UNSUCCESSFUL.. THE PATIENT WAS CONVERTED TO AN AUI AND A FEM-FEM BY-PASS WAS COMPLETED. THE PATIENT DID WELL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. THE PHYSICIAN STATED THAT THE EVENT WAS DEVICE AND PROCEDURE RELATED.

    Description of Event or Problem · 1

    THE LENGTH OF THE LOWEST RENAL TO THE DISTAL AORTA WAS ~75 MM AND THE CONTRALATERAL GATE DEPLOYS AT 74 MM. WHEN THE PHYSICIAN DEPLOYED DOWN TO THE GATE, THE GATE REMAINED CONSTRAINED BECAUSE IT DIDN¿T HAVE ENOUGH ROOM IN THE AORTA TO DEPLOY. BECAUSE THE GATE DIDN¿T DEPLOY, THE PHYSICIAN WAS NOT ABLE TO PASS A WIRE THRU AND THUS, HAD TO USE AN AUI DEVICE AND A FEM-FEM BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682655 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V05894366

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention