BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 20756422 · Received November 22, 2024

    Report

    Report Number
    9612164-2024-05486
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    April 20, 2023
    Report Date
    November 22, 2024
    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 REGARDING A JOURNAL ARTICLE ¿THE IMPACT OF OVERSIZING IN THORACIC ENDOVASCULAR AORTIC REPAIR ON LONG-TERM OUTCOMES IN UNCOMPLICATED TYPE B AORTIC DISSECTION: A SINGLE-CENTER RETROSPECTIVE STUDY¿. XIANG D, CHAI B, HUANG J, LIANG H, LIANG B, ZHAO H, ZHENG C. JOURNAL OF ENDOVASCULAR THERAPY. 2024 OCT;31(5):862-872. DOI: 10.1177/15266028231166282. 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 ¿  THE IMPACT OF OVERSIZING IN THORACIC ENDOVASCULAR AORTIC REPAIR ON LONG-TERM OUTCOMES IN UNCOMP LICATED TYPE B AORTIC DISSECTION: A SINGLE-CENTER RETROSPECTIVE STUDY¿.  THE STUDY PERIOD WAS OVER A EIGHT-YEARS. MULTIPLE MANUFACTURERS PRODUCTS ARE MENTIONED WITHIN THE ARTICLE INCLUDING VALIANT STENT GRAFTS. 226 PATIENTS WERE INCLUDED IN THE STUDY.  AMONG THE PATIENT POPULATION THE FOLLOWING MALFUNCTIONS OCCURRED: TYPE I ENDOLEAK PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MEDTRONIC STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATHS.  NO FURTHER INFORMATION WAS PROVIDED IN RELATION TO A MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2580154 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