BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 7746188 · Received August 3, 2018

    Report

    Report Number
    2953200-2018-01127
    Event Type
    Injury
    Date Received
    August 3, 2018
    Date of Event
    September 16, 2017
    Report Date
    October 3, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; ENDOVASCULAR SALVAGE OF RUPTURED TAAA FOLLOWING STENT GRAFT DISTRACTION AFTER TEVAR FOR TYPE B AORTIC DISSECTION. WEIGUO FU; BAOLEI GUO EUR J VASC ENDOVASC SURG (2017) 54, 743 DOI.ORG/10.1016/J.EJVS.2017.08.013. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC TYPE B AORTIC DISSECTION ON AN UNKNOWN DATE. A NON-MDT STENT GRAFT WAS ALSO IMPLANTED TO TREAT THE DISTAL ASPECT OF THE DISSECTION. IT WAS REPORTED THE PATIENT PRESENTED WITH PERSISTENT BACK PAIN DUE TO A RUPTURED 127 MM THORACO-ABDOMINAL ANEURYSM CAUSED BY MIGRATION OF STENT GRAFTS WITH TYPE III ENDOLEAK. AN EMERGENCY THORACIC ENDOVASCULAR AORTIC REPAIR WAS CARRIED OUT AND TWO VALIANT STENT GRAFTS WERE SUCCESSFULLY IMPLANTED. IT WAS REPORTED THE PATIENT RECOVERED WITHOUT ANY ENODLEAKS AND NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590177 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R