BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 22468664 · Received July 10, 2025

    Report

    Report Number
    9612164-2025-03393
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 2, 2025
    Report Date
    July 10, 2025
    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; ¿EXPRESSION OF PLASMA LEVELS OF MMP-2, MMP-9, TIMP-1, AND TIMP-2 IN PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS¿ LEITE TFO, DA SILVA ER, GOMES K, TIRAPELLI DPDC, JOVILIANO EE JORNAL OF VASCULAR BRASILIERIO. 2025 MAY 2;24: E20240163.  DOI: 10.1590/1677-5449.202401631 SECTION A AVERAGE VALUES. 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 ¿EXPRESSION OF PLASMA LEVELS OF MMP-2, MMP-9, TIMP-1, AND TIMP-2 IN PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS¿ THE TIME FRAME OF THIS STUDY WAS OVER A TWO-YEAR PERIOD. MULTIPLE MANUFACTURES PRODUCTS WERE IMPLANTED INCLUDING ENDURANT STENT GRAFTS. THE OBJECTIVE OF THIS STUDY WAS TO QUANTIFY AND EVALUATE MMP-2, MMP-9, TIMP-1, AND TIMP-2 EXPRESSION RESPONSE TO EVAR BASED ON SERUM ASSAYS AT 6-MONTH FOLLOW-UP. ALSO, A LITERATURE REVIEW WAS CARRIED OUT A WHERE A NUMBER OF STUDIES WERE INCLUDED WHICH HAD THE SAME OBJECTIVE. MEDTRONIC STENT GRAFTS TALENT, ANUERX AND ENDURANT WERE IMPLANTED IN THE PATIENT POPULATIONS WITHIN THE LITERATURE REVIEW. AMONG THE PATIENT POPULATION THAT RECEIVED ENDURANT STENT GRAFTS THE FOLLOWING MALFUNCTIONS OCCURRED: TYPE IA ENDOLEAK, TYPE IB ENDOLEAK, UNKNOWN ENDOLEAKS AMONG THE POPULATION THAT HAD ANEURRX AND TALENT STENT GRAFTS IMPLANTED, THE FOLLOWING MALFUNCTIONS WERE REPORTED: UNKNOWN ENDOLEAKS NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119246 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male