BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 20852722 · Received December 5, 2024

    Report

    Report Number
    9612164-2024-05801
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    August 26, 2024
    Report Date
    December 5, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿ THE ENZEN TRIAL: ANALYSIS OF EVAR ENDOPROSTHESIS ZENITH AND ENDURANT FOR INFRARENAL AORTOILIAC ANEURYSMS REGARDING OUTCOMES, ENDOLEAKS, AND REINTERVENTIONS¿.  DE ATHAYDE SOARES R, PORTELA MVV, AMARO K, NASSER AI, PEDROSA KL, SACILOTTO   JOURNAL OF ENDOVASCULAR THERAPY. 2024 AUG 26:15266028241270895.  DOI: 10.1177/15266028241270895.  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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING  ¿THE ENZEN TRIAL: ANALYSIS OF EVAR ENDOPROSTHESIS ZENITH AND ENDURANT FOR INFRARENAL AORTOILIAC ANEURYSMS REGARDING OUTCOMES, ENDOLEAKS, AND REINTERVENTIONS¿.  THE TIME FRAME OF THIS STUDY WAS OVER A THREE YEAR PERIOD. ENDURANT II STENT GRAFTS AND NON MDT STENT GRAFTS WERE IMPLANTED IN THE PATIENT POPULATION. 89 PATIENTS RECEIVED THE ENDURANT STENT GRAFT.  THE FOLLOWING MALFUNCTIONS WERE REPORTED AMONG THE PATIENT POPULATION: TYPE IB ENDOLEAK THE FOLLOWING ADVERSE EVENTS OCCURRED:   OCCLUSION, ISCHEMIA, INTERVENTION  PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A ENDURANT  PRODUCT CAUSED OR CONTRIBUTED TO ANY DEATHS.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049742 ENDURANT II STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDUR-II

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male