BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR VISION

    MDR report key: 21762543 · Received April 3, 2025

    Report

    Report Number
    2135147-2025-01700
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    March 10, 2025
    Report Date
    April 3, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067045775
    PMA / PMN Number
    P190023
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF IMPROPER OR INCORRECT PROCEDURE OR METHOD AND MIGRATION OR EXPULSION OF DEVICE (VENTRICULAR DIRECTION) 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 INFORMATION RECEIVED, THE REPORTED DEVICE MIGRATION IN VENTRICULAR DIRECTION APPEARS TO BE RELATED TO COMPLEX ANATOMY. THE REPORTED IMPROPER OR INCORRECT PROCEDURE OR METHOD WAS DUE TO USER RE-SHEATHING THE DEVICE MORE THAN 2 TIMES AND SNARING THE DEVICE AFTER DEPLOYMENT. THE REPORTED UNEXPECTED MEDICAL INTERVENTION AND SURGICAL INTERVENTION WERE A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM NAVITOR VALVE WAS SELECTED FOR IMPLANT. THE PATIENT HAD SUFFICEIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE. THE AORTIC ANGLE OF THE PATIENT WAS 54 DEGREES AND THE ANNULAR DIMENSIONS WERE: PERIMETER OF 80.0 MM, PERIMETER DERIVED Ø OF 25.5 MM, AREA OF 493.1 MM², AREA DERIVED Ø OF 25.1 MM, MIN Ø OF 22.5 MM, MAX Ø OF 28.8 MM, AVERAGE Ø OF 25.7 MM, AND ECCENTRICITY OF 0.22/0.78. DURING THE PROCEDURE, AFTER THE DEVICE WAS RELEASED AT A DEPTH 3MM NCC AND 5MM LCC, THE VALVE MIGRATED VENTRICULARLY UPON RELEASE. THE VALVE WAS SNARED INTO THE ASCENDING AORTA AND A 26MM NON-ABBOTT VALVE WAS IMPLANTED. IT WAS NOTED THAT PHYSICIAN RE-SHEATHED THE DEVICE MORE THAN 2 TIMES. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846998 NAVITOR VISION AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL NVRO-29 10230593 05415067045775

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention FLEXNAV DELIVERY SYSTEM