BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 9213863 · Received October 21, 2019

    Report

    Report Number
    9612164-2019-04445
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    June 12, 2019
    Report Date
    December 2, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH CONFIRMED THAT NONE OF THE ADVERSE EVENTS OR PATIENT DEATHS WERE ASSOCIATED WITH THE MEDTRONIC DEVICES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE DETAILS; TITLE: PREOPERATIVE INFERIOR MESENTERIC ARTERY EMBOLIZATION IS A COST-EFFECTIVE TECHNIQUE THAT MAY REDUCE THE RATE OF ANEURYSM SAC D IAMETER ENLARGEMENT AND REINTERVENTION AFTER EVAR AUTHORS: MICHAEL VAILLANT, PIERRE-ANTOINE BARRAL, JULIEN MANCINI, MARIANGELA DE MASI, LAURENCE BAL, PHILIPPE PIQUET, AND MARINE GAUDRY ANNALS OF VASCULAR SURGERY 2019; 60: 85¿94, DOI: HTTPS://DOI.ORG/10.1016/J.AVSG.2019.03.012. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT AND TALENT STENT GRAFT SYSTEMS WERE IMPLANTED IN A PATIENT GROUP FOR ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. NON-MEDTRONIC STENT GRAFTS WERE ALSO IMPLANTED IN THE PATIENT GROUP. THE AVERAGE ANEURYSM DIAMETER WAS 53 MM. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED IN THE PATIENT GROUP: MALFUNCTIONS: TYPE I ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008377 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR