BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 21332644 · Received February 7, 2025

    Report

    Report Number
    9612164-2025-00671
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 25, 2022
    Report Date
    February 7, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION REGARDING A JOURNAL ARTICLE ¿STROKE FOLLOWING THORACIC ENDOVASCULAR AORTIC REPAIR: DETERMINANTS, SHORT AND LONG TERM IMPACT¿. KAMMAN AV, VAN BAKEL PAJ, YANG B, WILLIAMS DM, KIM KM, KHAJA MS, MOLL FL, VAN HERWAARDEN JA, TRIMARCHI S, EAGLE KA, ELIASON JL, PATEL HJ. SEMINARS IN THORACIC AND CARDIOVASCULAR SURGERY VOLUME 35, NUMBER 1 HTTPS://DOI.ORG/10.1053/J.SEMTCVS.2021.08.030 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 ¿STROKE FOLLOWING THORACIC ENDOVASCULAR AORTIC REPAIR: DETERMINANTS, SHORT- AND LONG-TERM IMPACT¿. THE TIMEFRAME FOR THIS STUDY WAS OVER AN ELEVEN YEAR PERIOD. 479 PATIENTS UNDERWENT A TEVAR PROCEDURE AND WERE INCLUDED IN THIS STUDY. INDICATIONS FOR TEVAR INCLUDED ANEURYSMS (FUSIFORM OR SACCULAR), ACUTE OR CHRONIC DISSECTION, TRAUMATIC AORTIC INJURY AND OTHER INDICATIONS. MEDTRONIC TALENT AND VALIANT AS WELL AS NON-MDT STENT GRAFTS WERE IMPLANTED IN THE PATIENT POPULATION. AMONG THE PATIENT POPULATION THE FOLLOWING MALFUNCTIONS OCCURRED: ENDOLEAKS NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248244 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male