BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 7348476 · Received March 19, 2018

    Report

    Report Number
    2953200-2018-00372
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    September 4, 2017
    Report Date
    March 19, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; ANEURYSM WALL ENHANCEMENT DETECTED BY CONTRAST COMPUTED TOMOGRAPHY SCAN IS ASSOCIATED WITH ANEURYSM SHRINKAGE AFTER ENDOVASCULAR ANEURYSM REPAIR FOR ABDOMINAL AORTIC ANEURYSM. EISAKU ITO, NAOKI TOYA, SOICHIRO FUKUSHIMA, YURI MURAKAMI, TADASHI AKIBA, TAKAO OHKI, DIVISION OF VASCULAR SURGERY (E.I., N.T., S.F., Y.M.), DEPARTMENT OF SURGERY (T.A.), THE JIKEI UNIVERSITY KASHIWA HOSPITAL, KASHIWA; DEPARTMENT OF VASCULAR SURGERY, THE JIKEI UNIVERSITY SCHOOL OF MEDICINE, TOKYO (T.O.), JAPAN CIRC J 2018; (82):340 ¿ 345. OFF-LABEL FAILURE TO FOLLOW INSTRUCTIONS (PATIENT¿S ANATOMICAL FEATURES INDICATE LOW INSTRUCTIONS FOR USE). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT STENT GRAFT SYSTEMS' WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. ADVERSE EFFECTS: TYPE I ENDOLEAKS, TYPE II ENDOLOEAKS, TYPE III ENDOLEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192521 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR