BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK-CV-SR

    MDR report key: 22676189 · Received July 31, 2025

    Report

    Report Number
    9612164-2025-03747
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    November 8, 2024
    Report Date
    July 31, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿OUTCOMES OF ENDOVASCULAR REPAIR CONFINED TO THE ASCENDING THORACIC AORTA: A SYSTEMATIC REVIEW AND META-ANALYSIS¿ DEKORT J, MANDIGERS T, BISSACCO D, DOMANIN M, PIFFARETTI G, TWINE C, WANHAINEN A , VAN HERWAARDEN J, TRIMARCHI S, DE VINENTIIS EUR J VASC ENDOVASC SURG (2025) 69, 531E544 HTTPS://DOI.ORG/10.1016/J.EJVS.2024.10.049 A.2 A.3 AVERAGE 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 ¿ OUTCOMES OF ENDOVASCULAR REPAIR CONFINED TO THE ASCENDING THORACIC AORTA: A SYSTEMATIC REVIEW AND META-ANALYSIS¿ A SYSTEMATIC REVIEW AND META ANALYSIS WAS CARRIED OUT EXAMINING THE OUTCOMES OF ENDOVASCULAR REPAIR OF THE ASCENDING THORACIC AORTA . 94 STUDIES WERE INCLUDED. UNKNOWN MEDTRONIC AND NON MDT STENT GRAFTS WERE IMPLANTED IN THE STUDY POPULATION. AMONG THE PATIENT POPULATION THE FOLLOWING MALFUNCTIONS OCCURRED: IA ENDOLEAK, UNKNOWN ENDOLEAK NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277913 UNK-CV-SR SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male