BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 7396081 · Received April 4, 2018

    Report

    Report Number
    2953200-2018-00479
    Event Type
    Injury
    Date Received
    April 4, 2018
    Date of Event
    June 15, 2017
    Report Date
    April 4, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    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; PARALLEL PLACEMENT OF EXCLUDER LEGS FOR TREATMENT OF TYPE IIIB ENDOLEAKS CAUSED BY FABRIC TEAR AFTER ENDOVASCULAR ANEURYSM REPAIR (B)(6) MD, (B)(6) MD. (B)(6) MD. (B)(6) MD. (B)(6) MD. (B)(6) MD. (B)(6) MD AND (B)(6) MD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEMS WAS USED IN THE ENDOVASCULAR TREATMENT OF PATIENTS FOR AN UNKNOWN SIZE ANEURYSMS ON UNKNOWN DATES. ADVERSE EVENT; REINTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240725 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention