BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 20810856 · Received November 29, 2024

    Report

    Report Number
    9612164-2024-05670
    Event Type
    Malfunction
    Date Received
    November 29, 2024
    Date of Event
    July 19, 2024
    Report Date
    November 29, 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; ¿ENDOVASCULAR REPAIR FOR INFRA-RENAL AORTIC ANEURYSMS WITH SUPRA-RENAL FIXATION ENDOPROSTHESIS: RESULTS AND OUTCOMES¿. SOARES RA, AMARO K, NASSER AI, CURY MVM, NAKAMURA ET, PEDROSA KL, SACILOTTO R VASCULAR. 2024 JUL 19:17085381241264381. DOI: 10.1177/17085381241264381. 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 ¿ENDOVASCULAR REPAIR FOR INFRA-RENAL AORTIC ANEURYSMS WITH SUPRA-RENAL FIXATION ENDOPROSTHESIS: RESULTS AND OUTCOMES¿. THE TIME FRAME OF THE STUDY WAS OVER FIVE YEARS. MULTIPLE MANUFACTURES PRODUCTS WERE MENTIONED WITHIN THE ARTICLE. ENDURANT II STENT GRAFTS WERE IMPLANTED IN THE PATIENT POPULATION. 156 PATIENTS WERE INCLUDED IN THE STUDY. THE FOLLOWING MALFUNCTIONS WERE REPORTED; TYPE IA ENDOLEAK, TYPE III ENDOLEAK, IB ENDOLEAK THE FOLLOWING ADVERSE EVENTS WERE REPORTED; OCCLUSION, ISCHEMIA, RUPTURE, INTERVENTION PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A ENDURANT STENT GRAFT 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
    2619861 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