BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR

    MDR report key: 15287342 · Received August 24, 2022

    Report

    Report Number
    2135147-2022-00893
    Event Type
    Injury
    Date Received
    August 24, 2022
    Date of Event
    May 24, 2022
    Report Date
    August 24, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031587
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF VALVE MIGRATION RIGHT AFTER FULL DEPLOYMENT 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, INCLUDING THE VALVE MEETING STENT RADIAL FORCE SPECIFICATIONS, AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED, BUT THE LACK OF CALCIFICATION NOTED COULD HAVE CONTRIBUTED TO THE REPORTED MIGRATION. PER THE NAVITOR INSTRUCTIONS FOR USE, "POST-IMPLANTATION PRECAUTIONS: ONCE THE VALVE IS FULLY DEPLOYED, REPOSITIONING AND RETRIEVAL OF THE VALVE IS NOT POSSIBLE. ATTEMPTED RETRIEVAL (E.G., USE OF A GUIDEWIRE, SNARE, OR FORCEPS) MAY CAUSE AORTIC ROOT, CORONARY ARTERY, AND/OR MYOCARDIAL DAMAGE." THIS EVENT WAS INITIALLY REPORTED IN MFR REPORT REF # : 2135147-2022-00404-00 (B)(6) 2022. THIS EVENT WILL NOW BE CAPTURED IN THIS REPORT.

    Description of Event or Problem · 0

    THIS EVENT WAS INITIALLY REPORTED IN MFR REPORT REF # : 2135147-2022-00404-00 (B)(6) 2022. THIS EVENT WILL NOW BE CAPTURED IN THIS REPORT. IT WAS REPORTED THAT ON (B)(6) 2022 A 25MM NAVITOR (SERIAL NUMBER (B)(4) WAS SELECTED FOR IMPLANTATION. THE SIZING OF THE ANNULAR DIMENSIONS WAS 21-23MM. THERE WAS NO INTERACTION BETWEEN THE DELIVERY SYSTEM AND THE DEPLOYED VALVE, AND THERE WERE NO DIFFICULTIES IN DEPLOYING VALVE. AFTER THE DEVICE WAS RELEASED WITH A DEPTH OF 1MM AT THE NON-CORONARY CUSP (NCC) AND 2MM AT THE LEFT CORONARY CUSP (LCC), THE VALVE MIGRATED UPWARDS. IT WAS NOTED THAT THERE WAS LITTLE CALCIFICATION ON THE ANNULUS AND THAT A BALLOON VALVULOPLASTY WAS NOT DONE PRIOR TO IMPLANT. THE DEVICE WAS SNARED AND MOVED TO THE ASCENDING AORTA, AND THE PHYSICIAN KNEW THAT THIS WAS AGAINST THE INSTRUCTIONS FOR USE (IFU). A 23MM NON-ABBOTT DEVICE WAS IMPLANTED WITHIN THE FIRST VALVE TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063767 NAVITOR AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 8347229 05415067031587

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention SMALL FLEXNAV DELIVERY SYSTEM