BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT NAVION

    MDR report key: 19238229 · Received May 3, 2024

    Report

    Report Number
    9612164-2024-02132
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    May 2, 2023
    Report Date
    May 3, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ROLE OF INITIAL MEDICAL TREATMENT AND EFFECTIVENESS OF THORACIC ENDOVASCULAR AORTIC REPAIR FOR ACUTE TYPE A AORTIC DISSECTION WITH THROMBOSED FALSE LUMEN MASADA K, SHINZATO K, KOIZUMI S, YOKAWA K, KASAI M, INOUE Y ET AL.  EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 2023, 63(5), EZAD102 DOI:10.1093/EJCTS/EZAD102 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. 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

    OVER A 6 YEAR PERIOD, 60 PATIENTS WITH A ACUTE TYPE A AORTIC DISSECTION (AAAD) WITH THROMBOSED FALSE LUMEN (T-FL) OF THE ASCENDING AORTA WERE TREATED . INITIAL MEDICAL TREATMENT WAS GIVEN TO 27 UNCOMPLICATED PATIENTS WITH ASCENDING AORTIC DIAMETER 50 MM AND ASCENDING T-FL THICKNESS WHILE 33 PATIENTS RECEIVED EMERGENCY SURGICAL  REPAIR . THE SURGICAL REPAIR WAS EITHER AND OPEN REPAIR OR TEVAR. 15 PATIENTS UNDERWENT A TEVAR PROCEDURE. 3 OF THESE PATIENTS WERE IMPLANTED WITH A VALIANT NAVION STENT GRAFT WHILE THE OTHERS RECEIVED NON MDT STENT GRAFTS.  EMERGENCY TEVAR WAS PERFORMED IN 7 (47%), INCLUDING 2 UNCOMPLICATED PATIENTS WITHOUT THE ANATOMICAL INDICATION OF MEDICAL TREATMENT AND 5 COMPLICATED PATIENTS. FOR THE TEVAR, THE PROXIMAL LANDING ZONE WAS AT ZONE 2 IN 5 (33%), AT ZONE 3 IN 8 (53%) AND AT ZONE 4 IN 2 (13%) PATIENTS. THE FOLLOWING MALFUNCTION WERE REPORTED;  MALAPPOSITION (2 CASES OF PROGRESSION OF BIRD -BEAK CONFIGURATION UP TO 2 YEARS AFTER TEVAR )  THE FOLLOWING ADVERSE EVENS WERE REPORTED;  STROKE, DISSECTION , 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
    1022082 VALIANT NAVION SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-NAV

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown