BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ANCHOR SYSTEM - HELI-FX AAA

    MDR report key: 22217736 · Received June 17, 2025

    Report

    Report Number
    9612164-2025-02966
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    May 8, 2023
    Report Date
    July 4, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    OTD
    PMA / PMN Number
    K140036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿FENESTRATED ENDOVASCULAR AORTIC REPAIR AFTER FAILED E NDOVASCULAR AORTIC REPAIR¿ TAHER F, PLIMON M, WALTER C, WEISS G, KLIEWER M, ASSADIAN A, FALKENSAMMER J JOURNAL OF ENDOVASCULAR THERAPY 2025, VOL. 32(1) 233¿241 HTTPS://DOI.ORG/10.1177/15266028231174113 A2: AVERAGE AGE A3A: MAJORITY SEX 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.

    Additional Manufacturer Narrative · 0

    B5; ADDITIONAL INFORMATION RECEIVED: PER THE AUTHOR , THE TERM ¿FAILED¿ EVAR IS NOT REFERRING TO DEVICE FAILURES OR ADVERSE EVENTS, BUT RATHER PROGRESSION OF AORTIC DISEASE WHICH LEAD TO FEVAR IN EVAR DUE TO INSUFFICIENT PROXIMAL LANDING ZONE. ANOTHER REASON FOR THIS (ESPECIALLY WHEN THIS OCCURS EARLY) IS WHEN EVAR IS DONE OUTSIDE OF IFU (WITH INSUFFICIENT PROXIMAL LANDING ZONE). IN THIS STUDY, THESE PROCEDURES USUALLY OCCURRED A RELATIVELY LONG TIME AFTER EVAR (IN THE CASE OF THE ENDURANT DEVICES IN OUR STUDY UP TO 10 YEARS AFTER THE ENDURANT EVAR). NOTEWORTHY, THIS STUDY FOUND THAT THE STEERABLE SHEATH PROVIDED BY MEDTRONIC (TOURGUIDE) MAY HAVE BEEN INVALUABLE IN PERFORMING THESE COMPLEX CASES (WITH A POSITIVE EFFECT ON SUCCESS OF AND, ANECDOTALLY, TIME REQUIRED FOR CANNULATION AND CONNECTION OF FENESTRATIONS). 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 ¿FENESTRATED ENDOVASCULAR AORTIC REPAIR AFTER FAILED ENDOVASCULAR AORTIC REPAIR¿ THE TIME FRAME OF THIS STUDY WAS OVER A SEVEN YEAR PERIOD. THIS RETROSPECTIVE STUDY ASSESSED THE TECHNICAL OUTCOME OF FENESTRATED EN DOVASCULAR AORTIC REPAIR (FENESTRATED EVAR; FEVAR) AFTER PRIOR EVAR. 35 PATIENTS WERE INCLUDED WHO MET THE CRITERIA OF UNDERGOING A FEVAR AFTER FAILED EVAR. PRIMARY STENT GRAFTS USED IN THE EVAR PROCEDURE INCLUDED MDT ENDURANT, TALENT STENT GRAFT AS WELL AS NON-MDT STENT GRAFTS. THREE CASES ALSO HAD ENDOANCHORS IMPLANTED DURING THE INDEX PROCEDURE. TIME FROM EVAR IMPLANTATION TO FEVAR WAS 51.7±32.9 MONTHS. NON-MDT CUSTOM MADE STENT GRAFTS WERE IMPLANTED DURING THE FEVAR PROCEDURES. AMONG THE PATIENT POPULATION THE FOLLOWING MALFUNCTIONS OCCURRED (CONFIRMED AS AN INDICATION TO PERFORM THE FEVAR: IA ENDOLEAK NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594559 ENDO ANCHOR SYSTEM - HELI-FX AAA ENDOVASCULAR SUTURING SYSTEM OTD MEDTRONIC IRELAND SA-85

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention