BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ANCHOR SYSTEM - HELI-FX AAA

    MDR report key: 19190670 · Received April 26, 2024

    Report

    Report Number
    9612164-2024-02003
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    August 12, 2023
    Report Date
    May 1, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    OTD
    PMA / PMN Number
    K140036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: MIDTERM OUTCOMES OF PRIMARY AND SECONDARY USE OF AN ENDOANCHOR SYSTEM FOR THORACIC AND ABDOMINAL AORTIC ENDOVASCULAR AORTIC REPAIR ABDEL-HADI ET AL, J VASC INTERV RADIOL 2023; 34:1938¿1945 HTTPS://DOI.ORG/10.1016/J.JVIR.2023.08.004 A2: MEAN AGE A3: MEAN GENDER D6A: EXACT DATE OF IMPLANT UNKNOWN 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

    CORRECTION: AWARE DATE OF COMPLAINT UPDATED TO (B)(6) 2024. 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

    HELI-FX ENDOANCHORS WERE IMPLANTED IN PATIENTS DURING PRIMARY AND SECONDARY PROCEDURES FOR PROPHYALTIC AND INTERVENTION ON UNKNOWN DATES. ONE PATIENT WAS TREATED WITH A VALIANT THE FOLLOWING ADVERSE EVENTS WERE REPORTED: DISLODGED ENDOANCHOR 26 MONTHS POST THE INDEX PROCEDURE IN A STABLE POSITION AT THE FLOW DIVIDER OF GRAFT. THE CAUSE IS UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308156 ENDO ANCHOR SYSTEM - HELI-FX AAA ENDOVASCULAR SUTURING SYSTEM OTD MEDTRONIC IRELAND SA-85

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown