BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 21458829 · Received February 25, 2025

    Report

    Report Number
    9612164-2025-01016
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    April 26, 2022
    Report Date
    February 25, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿DEVELOPMENT AND COMPARISON OF MULTIMODAL MODELS FOR P REOPERATIVE PREDICTION OF OUTCOMES AFTER ENDOVASCULAR ANEURYSM REPAIR¿. WANG Y, ZHOU M, DING Y, LI X, ZHOU Z, SHI Z AND FU W (2022) FRONT. CARDIOVASC. MED. 9:870132. DOI: 10.3389/FCVM.2022.870132 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 ¿ DEVELOPMENT AND COMPARISON OF MULTIMODAL MODELS FOR PREOPERATIVE PREDICTION OF OUTCOMES AFTER EN DOVASCULAR ANEURYSM REPAIR THE TIME FRAME OF THIS STUDY WAS OVER A NINE-YEAR PERIOD. MULTIPLE MANUFACTURES PRODUCTS WERE IMPLANTED. ENDURANT STENT GRAFTS WERE IMPLANTED IN THE PATIENT POPULATION. THE AIM OF THIS STUDY WAS TO DEVELOP AND COMPARE MULTIMODAL MODELS FOR PREDICTING OUTCOMES AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) BASED ON MORPHOLOGICAL, DEEP LEARNING (DL), AND RADIOMIC FEATURES. AMONG THE PATIENT POPULATION THE FOLLOWING MALFUNCTIONS OCCURRED: IA ENDOLEAK, IB ENDOLEAK, TYPE III ENDOLEAK NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406982 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male