BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT NAVION

    MDR report key: 19219276 · Received May 1, 2024

    Report

    Report Number
    9612164-2024-02069
    Event Type
    Injury
    Date Received
    May 1, 2024
    Date of Event
    July 25, 2022
    Report Date
    May 1, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: FABIEN VECCHINI, GAUTIER HAUPERT, ANNA BAUDRY, JULIEN MANCINI , LUCIE DUMUR, ROBERT MARTINEZ, PHILIPPE PIQUET, JEAN PICQUET, AND MARINE GAUDRY,. RISK FACTORS FOR INCOMPLETE AORTIC REMODELING WITH STENT-ASSISTED BALLOON-INDUCED INTIMAL DISRUPTION AND RELAMINATION IN AORTIC DISSECTION REPAIR FOR COMPLICATED AORTIC DISSECTION: RESULTS OF A MULTIC. JOURNAL OF ENDOVASCULAR THERAPY VOL. 31(1) 69¿ 79 2024. DOI: 10.1177/15266028221111984 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. A.2 <(>&<)> 3.B AVERAGE VALUES USED 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 NAVION STENT GRAFTS AND NON MDT STENT GRAFTS WERE IMPLANTED IN 59 PATIENTS IN THE TREATMENT OF TYPE B AORTIC DISSECTION IN 34 CASES AND RESIDUAL AORTIC DISSECTION AFTER TYPE A REPAIR IN 24 CASES, OVER A TWO YEAR PERIOD. 47 PATIENTS WERE TREATED USING THE STABILISE TECHNIQUE . A HYBRID TREATMENT WITH SUPRA-AORTIC TRUNK DEBRANCHING WAS PERFORMED IN 35 CASES, OPEN SURGERY WITH A NON MDT SURGICAL GRAFT IN 2 CASES, AND FENESTRATED OR BRANCHED AORTIC ARCH ENDOPROSTHESIS IN 2 CASES (1 BRANCHED ENDOPROSTHESIS FOR A CHRONIC TYPE B AD TREATED FOR ANEURYSMAL EVOLUTION AND 1 HOMEMADE IN SITU LASER FENESTRATION FOR A CHRONIC RESIDUAL AD TREATED FOR PAIN AND RAPID AORTIC GROWTH). IN OTHER CASES, TEVAR ALONE WAS PERFORMED.  THE FOLLOWING MALFUNCTIONS WERE REPORTED;  TYPE IA, TYPE IIIA ENDOLEAK, DEPLOYMENT (BIRD-BEAK CONFIGURATION) THE FOLLOWING ADVERSE EVENTS WERE REPORTED;  STROKE, RUPTURE, SPINAL CORD ISCHEMIA, DISSECTION, ACUTE RENAL INSUFFICIENCY, ANGINA, FEMORAL FALSE ANEURYSM, THROMBOSIS, TAMPONADE, FISTULA, LOWER LIMB ISCHEMIA, BASILAR VERTEBRAL INSUFFICIENCY, LYMPHOCELE,  RE-INTERVENTION  PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A VALIANT NAVION STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138171 VALIANT NAVION SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-NAV

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown Other| R