BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 16993758 · Received May 24, 2023

    Report

    Report Number
    9612164-2023-02196
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    March 10, 2023
    Report Date
    May 24, 2023
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; MIDTERM CHANGES IN ILIAC LIMB APPOSITION AFTER ENDOVASCULAR AORTIC ANEURYSM REPAIR KOOIJMAN MA, SCHUURMANN RC, KROPMAN RH, ELZEFZAF NY, WILLE J, TIELLIU IFJ, ET AL. J CARDIOVASC SURG 2023;64:159-66 DOI: 10.23736/S0021-9509.23.12582-1 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ENDURANT II STENT GRAFTS WERE IMPLANTED IN EVAR PROCEDURES ON UNKNOWN DATES OVER A TWO YEAR PERIOD . 50 PATIENTS WERE INCLUDED IN THE STUDY WHICH AIM WAS TO MEASURE ILIAC APPOSITION OF ENDOGRAFT LIMBS ON THE FIRST POST-EVAR COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SCAN AND ON THE LATEST AVAILABLE FOLLOW-UP CTA SCAN. THE FOLLOWING MALFUNCTIONS WERE IDENTIFIED ; IB ENDOLEAK, MIGRATION , INADEQUATE SEAL THE FOLLOWING ADVERSE EVENTS WERE IDENTIFIED; RUPTURE, OCCLUSION, ANEURYSM ENLARGEMENT, RE-INTERVENTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648074 ENDURANT II STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDUR-II

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male