BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 8008377 · Received October 26, 2018

    Report

    Report Number
    9612164-2018-02946
    Event Type
    Injury
    Date Received
    October 26, 2018
    Date of Event
    May 15, 2018
    Report Date
    January 15, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL INFORMATION: TITLE: OUTCOMES OF PLANNED TWO-STAGE HYBRID AORTIC REPAIR WITH DACRON-REPLACED PROXIMAL LANDING ZONE AUTHORS:DAVID N. RANNEY, BABATUNDE A. YEROKUN, EHSAN BENRASHID, MUATH BISHAWI, ADAM WILLIAMS, RICHARD L. MCCANN AND G. CHAD HUGHES THE SOCIETY OF THORACIC SURGEONS, 2018;106:1136¿42, DOI.ORG/0.1016/J.ATHORACSUR.2018.04.044. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    UPDATED POST INVESTIGATION CLOSURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT AND TALENT SENT GRAFT SYSTEMS WERE IMPLANTED INTO 3 PATIENTS (OUT OF A STUDY GROUP OF 34 PATIENTS) FOR THE SECOND STAGE OF THORACIC AORTIC REPAIR FROM JANUARY 2006 AND AUGUST 2017. THE FIRST STAGE OF TREATMENT INVOLVED EITHER HYBRID ARCH REPAIR (HAR) OR TOTAL ARCH REPLACEMENT (TAR). IT WAS REPORTED THAT DURING THAT TIME THE FOLLOWING ADVERSE EVENTS WERE REPORTED IN THE ENTIRE PATIENT GROUP: SERIOUS INJURY STROKE PULMONARY EMBOLISM ALLERGIC REACTION CARDIO PULMONARY DISEASE SEPSIS RETROGRADE TYPE A DISSECTION REINTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849466 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention