BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ANCHOR SYSTEM - HELI-FX AAA

    MDR report key: 9606456 · Received January 20, 2020

    Report

    Report Number
    9612164-2020-00316
    Event Type
    Injury
    Date Received
    January 20, 2020
    Date of Event
    October 27, 2019
    Report Date
    January 20, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    OTD
    PMA / PMN Number
    K140036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; TECHNICAL APPROACH AND OUTCOMES OF FAILED INFRARENAL ENDOVASCULAR ANEURYSM REPAIRS RESCUED WITH FENESTRATED AND BRANCHED ENDOGRAFTS. HTTPS://DOI.ORG/10.1186/S42155-019-0075-Z JESSE MANUNGA, LARISSA I. STANBERRY, PETER ALDEN, JASON ALEXANDER, NEDAA SKEIK, ELLIOT STEPHENSON, JESSICA TITUS, JOSEPH KARAM, XIAOYI TENG AND TIMOTHY SULLIVAN CVIR ENDOVASCULAR 2019 VOL 2 ISSUE 1. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL AORTIC STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON AN UNKNOWN DATE. HELI-FX ENDOANCHORS WERE ALSO IMPLANTED ON AN UNKNOWN DATE FOR ENDOLEAK REPAIR. A RE-INTERVENTION PROCEDURE WAS CARRIED OUT FOR TREATMENT FAILURE USING A NON-MDT FENESTRATED STENT GRAFT. THE INDICATION FOR RE-INTERVENTION WAS EITHER A TYPE IA ENDOLEAK, A TYPE IB ENDOLEAK OR ENDOTENSION. THE PATIENT ALSO MAY HAVE PRESENTED WITH A RUPTURE THAT REQUIRED EMERGENCY RE-INTERVENTION TREATMENT FAILURE OF THE INITIAL EVAR WERE REPORTED TO BE DUE TO STENT GRAFT MIGRATION, DISEASE PROGRESSION, SHORT INITIAL NECK OR, UNABLE TO BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70818 ENDO ANCHOR SYSTEM - HELI-FX AAA ENDOVASCULAR SUTURING SYSTEM OTD MEDTRONIC IRELAND SA-85

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention