BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 22392926 · Received July 3, 2025

    Report

    Report Number
    9612164-2025-03270
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    April 9, 2023
    Report Date
    July 3, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    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; ¿ LONG-TERM OUTCOMES OF THORACIC ENDOVASCULAR REPAIR WITH QUICK FENESTRATER ASSISTED IN SITU FENESTRATION FOR TYPE B AORTIC DISSECTION¿ HE T, BAI J, WU J, LIU Y , QU L VASCULAR 2024, VOL. 32(5) 937¿945 DOI: 10.1177/17085381221140168 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 ¿LONG-TERM OUTCOMES OF THORACIC ENDOVASCULAR REPAIR WITH QUICK FENESTRATER ASSISTED IN SITU FENESTRATION FOR TYPE B AORTIC DISSECTION¿ THE TIME FRAME OF THIS STUDY WAS OVER A ONE YEAR PERIOD. THE AIM OF THE STUDY WAS TO REPORT THE LONG-TERM OUTCOMES OF PATIENTS WITH TYPE B AORTIC DISSECTION (TBAD) TREATED WITH THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) AND QUICK FENESTRATED (QF)-ASSISTED IN SITU FENESTRATION (ISF). A VALIANT STENT GRAFT AND NON MDT STENT GRAFTS WERE IMPLANTED IN THE STUDY COHORT OF 15 PATIENTS. AMONG THE PATIENT POPULATION THE FOLLOWING MALFUNCTIONS OCCURRED: 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
    1583044 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male