BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR VISION

    MDR report key: 20498633 · Received October 21, 2024

    Report

    Report Number
    2135147-2024-05229
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    September 26, 2024
    Report Date
    January 17, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067045782
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF VALVE UNDEREXPANSION, CENTRAL REGURGITATION, PERIVALVULAR LEAK (PVL), INCOMPLETE COAPTATION, PATIENT DEVICE INTERACTION PROBLEM, HEART FAILURE, AND HOSPITALIZATION WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION AND CINE REVIEW, THE CAUSE OF THE REPORTED VALVE UNDEREXPANSION, CENTRAL REGURGITATION, PVL, AND INCOMPLETE COAPTATION COULD NOT BE CONCLUSIVELY DETERMINED. THE REPORTED HOSPITALIZATION AND UNEXPECTED MEDICAL INTERVENTION WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. DURING THE PROCEDURE, A POST-BALLOON AORTIC VALVULOPLASTY (POST-BAV) WAS PERFORMED. FOLLOWING THE PROCEDURE, THE PATIENT WAS ADMITTED FOR HEART FAILURE AND TREATED WITH DIURETICS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM NAVITOR VISION TRANSCATHETER AORTIC VALVE (SERIAL: (B)(6)) WAS CHOSEN FOR IMPLANTATION UTILIZING A SMALL FLEXNAV DELIVERY SYSTEM (LOT: 9119719). PRE-DILATATION WAS PERFORMED WITH CAMEL 20 MM (GOODMAN CO., LTD.) BALLOON. SIGNIFICANT CALCIFICATION WAS OBSERVED IN THE STJ (SINOTUBLAR JUNCTION), BUT NO CALCIFICATION THAT WOULD CREATE A RISK FOR NUE WAS SEEN IN THE ANNULUS OR SOV (SINUS OF VALSALVA). DURING FIRST DEPLOYMENT ATTEMPT, NON-UNIFORM EXPANSION OCCURRED AND THE DEPTH WAS SHALLOW SO THE NAVITOR WAS RECAPTURED. SECOND ATTEMPT WAS STILL TOO SHALLOW. ON THE THIRD ATTEMPT, 80% ACHIEVED WITHOUT NON-UNIFORM EXPANSION AT DEPTH OF 5MM NON CORONARY CUSP, 3MM LEFT CORONARY CUSP. MILD PARAVALVULAR LEAK WAS PRESENT AND SLIGHT CENTRAL REGURGITATION. FULL DEPLOYMENT WAS PERFORMED. THERE WAS NO MIGRATION. AFTER GUIDEWIRE REMOVAL, MILD PVL WAS STILL OBSERVED ALONG WITH CENTRAL REGURGITATION. ON CT, THE VALVE WAS OBSERVED TO BE POORLY EXPANDED. POST BALLOON ANNULAR VALVULOPLASTY WAS PERFORMED WITH A Z-MED 22MM BALLOON. THE CT SHOWED THAT THE VALVE AREA OF THE RCC WAS LESS THAN HALF OF THAT OF THE LCC. ALSO, IN THE VALVE AREA OF THE RCC, THERE WERE PARTS WITH CONTRAST MEDIA AND PARTS WITHOUT, SHOWING A BLACK-AND-WHITE CONTRAST WHICH IS NOT SEEN IN A REGULAR CT SCAN (IT LOOKED LIKE A POLKA-DOT PATTERN.) - INDICATING THAT COAPTATION WAS POOR. THE LEAFLET MOVEMENT WAS THOUGHT TO DUE TO POOR EXPANSION. ALTHOUGH THE LVOT (LEFT VENTRICULAR OUTFLOW TRACT) WAS ELLIPTICAL IN PRE-PROCEDURAL ANALYSIS, THE VALVE EXPANDED TO A PERFECT CIRCLE, WITH NO STENT DEVIATION OBSERVED IN THIS AREA. THE ECHO FOLLOW-UP ON (B)(6) 2024 SHOWED AORTIC REGURGITATION REMAINED MILD. PATIENT WAS HOSPITALIZED FOR MONITORING. ON (B)(6) 2024, THE REGURGITATION HAD WORSENED TO SEVERE. DUE TO HEART FAILURE, PATIENT WAS GIVEN DIURETICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149061 NAVITOR VISION AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 10313927 05415067045782

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Female Hospitalization| R SMALL FLEXNAV DELIVERY SYSTEM