BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 16520535 · Received March 10, 2023

    Report

    Report Number
    9612164-2023-01069
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    August 18, 2022
    Report Date
    March 10, 2023
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    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 OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: PRE-OPERATIVE AORTIC NECK CHARACTERISTICS AND POST-OPERATIVE SEALING ZONE AS PREDICTORS OF TYPE 1A ENDOLEAK AND MIGRATION AFTER ENDOVASCULAR ANEURYSM REPAIR: A SYSTEMATIC REVIEW AND META-ANALYSIS ZUIDEMA ET AL, EUR J VASC ENDOVASC SURG (2022) 64, 475E488 HTTPS://DOI.ORG/10.1016/J.EJVS.2022.08.017. 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.

    Description of Event or Problem · 0

    TALENT STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: TYPE IA ENDOLEAK, TYPE IB ENDOLEAK, TYPE III ENDOLEAKS AND MIGRATION. THE CAUSE OF THE ENDOLEAKS AND MIGRATIONS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218222 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-TAL AAA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown