BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ANCHOR SYSTEM - HELI-FX AAA

    MDR report key: 9589954 · Received January 15, 2020

    Report

    Report Number
    9612164-2020-00228
    Event Type
    Injury
    Date Received
    January 15, 2020
    Date of Event
    May 30, 2018
    Report Date
    January 15, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    OTD
    PMA / PMN Number
    K140036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HELI-FX ENDOANCHORING SYSTEM WAS USED IN THE ENDOVASCULAR TREATMENT OF THE PATIENT WITH A 87MM ABDOMINAL AORTIC ANEURYSM. THE PATIENT PREVIOUSLY HAD A NON MDT (E-TEGRA JOTEC) STENT GRAFT IMPLANTED A WEEK PREVIOUSLY AND 8 ENDOANCHORS WERE IMPLANTED FOR THE TREATMENT OF A TYPE IA ENDOLEAK. IT WAS REPORTED THAT THE ENDOLEAK WAS RESOLVED AFTER PLACEMENT OF THE HELI-FX ENDOANCHORS. IT WAS REPORTED THAT THE PATIENT HAD RENAL FAILURE, DIAGNOSED VIA BLOOD TESTING 3 MONTHS LATER AND THAT THIS WAS ASSESSED BY THE INVESTIGATOR AS RELATED TO THE STENT GRAFT AND HELI-FX DEVICE. THE PATIENT HAD MEDICATION AND A SECONDARY INTERVENTION TO IMPLANT A RENAL STENT BUT THIS WAS UNSUCCESSFUL AND THE EVENT IS UNRESOLVED. THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS CONTINUING WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53281 ENDO ANCHOR SYSTEM - HELI-FX AAA ENDOVASCULAR SUTURING SYSTEM OTD MEDTRONIC IRELAND SA-85 0008948311

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention