BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 19190868 · Received April 26, 2024

    Report

    Report Number
    9612164-2024-02007
    Event Type
    Injury
    Date Received
    April 26, 2024
    Date of Event
    April 1, 2023
    Report Date
    April 26, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; DETERMINATION OF THE GAINED PROXIMAL SEALING ZONE LENGTH AFTER DEBRANCHING OF THE LEFT SUBCLAVIAN ARTERY IN THORACIC ENDOVASCULAR AORTIC REPAIR DIELEMAN IM, ZUIDEMA R, DE BEAUFORT HW, GALLITTO E, SPATH P, LOGIACCO A, ET AL. THE JOURNAL OF  CARDIOVASCULAR SURGERY 2023;64:134-41. DOI: 10.23736/S0021-9509.23.12578-X. 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

    VALIANT AND NON MDT STENT GRAFTS WERE IMPLANTED IN 22 PATIENTS FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC ANEURYSMS ON UNKNOWN DATES OVER A 10 YEAR PERIOD.  DURING THE TEVAR, THE PATIENTS ALSO UNDERWENT SURGICAL REVASCULARIZATION OF THE LSA TO EXTEND PROXIMAL SEALING IN ZONE 2. THE FOLLOWING MALFUNCTIONS WERE REPORTED;  TYPE IA ENDOLEAK, TYPE IB ENDOLEAK, TYPE III ENDOLEAK (PROBABLY FABRIC TEAR) , DEPLOYMENT (BIRDBEAK CONFIGURATION)  THE FOLLOWING ADVERSE EVENTS WERE REPORTED;  SPINAL CORD ISCHEMIA, PARAPLEGIA, RE-INTERVENTION  PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A VALIANT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2038888 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown Required Intervention