BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ANCHOR SYSTEM - HELI-FX AAA

    MDR report key: 20075832 · Received August 27, 2024

    Report

    Report Number
    9612164-2024-03874
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    March 12, 2024
    Report Date
    August 27, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    OTD
    PMA / PMN Number
    K140036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION ENTITLED; USE OF ENDOANCHORS DURING INDEX ENDOVASCULAR AORTIC ANEURYSM REPAIR IN PATIENTS WITH HOSTILE PROXIMAL AORTIC NECK ANATOMY SIVAK J, SUCHAC M, DAXNER M, KMETKOVA K, SYKORA J, ZAPLETALOVA J, ZELENAK K, BRATISL LEK LISTY. 2024;125(6):347-353. DOI: 10.4149/BLL_2024_52. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING A SINGLE CENTER RETROSPECTIVE STUDY ¿ USE OF ENDOANCHORS DURING INDEX ENDOVASCULAR AORTIC ANEURYSM REPAIR IN PATIENTS WITH HOSTILE PROXIMAL AORTIC NECK ANATOMY¿ . 24 PATIENTS WERE INCLUDED IN THE STUDY . THE MEDIAN FOLLOW-UP PERIOD WAS 22.5 MONTHS. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ENDURANT II AND ENDOANCHORS AMONG THE PATIENTS THE FOLLOWING DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: INACCURATE DELIVERY, IA ENDOLEAK, IB ENDOLEAK, IIIA ENDOLEAK THE FOLLOWING ADVERSE EVENTS INCLUDED: ISCHEMIA, THROMBOSIS, ANEURYSM ENLARGEMENT NO ANEURYSM RELATED DEATHS OCCURRED DURING THE FOLLOW-UP PERIOD NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219549 ENDO ANCHOR SYSTEM - HELI-FX AAA ENDOVASCULAR SUTURING SYSTEM OTD MEDTRONIC IRELAND SA-85

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown