BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 17214099 · Received June 27, 2023

    Report

    Report Number
    2135147-2023-02820
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    June 6, 2023
    Report Date
    August 4, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031587
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. H6 HEALTH EFFECT - CLINICAL CODE: CODE 4582 REMOVED.

    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) 2023, A 25MM NAVITOR VALVE (SERIAL#: (B)(6)) WAS CHOSEN FOR IMPLANT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) USING A FLEXNAV DELIVERY SYSTEM (LOT#: 8424385). THE NATIVE VALVE HAD MILD CALCIUM WITH DIMENSIONS OF 65.8MM PERIMETER AND 341.8 MM AREA. THERE WAS INITIAL DIFFICULTY INSERTING THE DELIVERY SYSTEM INTO THE FEMORAL ARTERY. ONCE THE SYSTEM WAS IN THE AORTA, THE DEVICE WAS PARTIALLY DEPLOYED. DEPTH WAS TOO SHALLOW SO THE DEVICE WAS ATTEMPTED TO BE RECAPTURED. THE VALVE CAPSULE STARTED TO ACCORDION AND COULD ONLY RECAPTURE PARTIALLY. 4MM OF VALVE WAS STILL OUT OF THE CAPSULE. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND THE PATIENT REMAINED STABLE. A REPLACEMENT 25MM NAVITOR VALVE (SERIAL#: (B)(6)) WAS THEN ATTEMPTED TO BE IMPLANTED UTILIZING A REPLACEMENT FLEXNAV DELIVERY SYSTEM (LOT: 8813401) . THE VALVE WAS DEPLOYED AT A DEPTH OF 0MM ON THE NON-CORONARY CUSP AND 1MM ON THE LEFT CORONARY CUSP. AN ANGIOGRAM WAS PERFORMED AFTER DEPLOYMENT, AND THE VALVE HAD MIGRATED TO 4MM DEPTH ON THE NON CUSP AND 1MM DEPTH ON THE LEFT CUSP. THE MIGRATED VALVE DID NOT BLOCK ANY ARTERIES AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE FOLLOWING THE MIGRATION. THE PATIENT DEVELOPED MODERATE AORTIC INSUFFICIENCY. A NON-ABBOTT VALVE WAS IMPLANTED WITHIN THE NAVITOR VALVE VIA VALVE-IN-VALVE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT AFTER THE 25MM NAVITOR VALVE (SERIAL#: (B)(6)) WAS IMPLANTED, AN ANGIOGRAM WAS PERFORMED AFTER DEPLOYMENT WHICH REVEALED THAT THE VALVE HAD MIGRATED BUT STILL REMAINED WITHIN THE AORTIC ANNULUS. A NON-ABBOTT VALVE WAS IMPLANTED WITHIN THE NAVITOR VALVE VIA VALVE-IN-VALVE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM NAVITOR VALVE (SERIAL#: (B)(6)) WAS CHOSEN FOR IMPLANT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) USING A FLEXNAV DELIVERY SYSTEM (LOT#: 8424385). THERE WAS INITIAL DIFFICULTY INSERTING THE DELIVERY SYSTEM INTO THE FEMORAL ARTERY. ONCE THE SYSTEM WAS IN THE AORTA, THE DEVICE WAS PARTIALLY DEPLOYED. DEPTH WAS TOO SHALLOW SO THE DEVICE WAS ATTEMPTED TO BE RECAPTURED. THE VALVE CAPSULE STARTED TO ACCORDION AND COULD ONLY RECAPTURE PARTIALLY. 4MM OF VALVE WAS STILL OUT OF THE CAPSULE. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND THE PATIENT REMAINED STABLE. A REPLACEMENT 25MM NAVITOR VALVE (SERIAL#: (B)(6)) WAS THEN ATTEMPTED TO BE IMPLANTED UTILIZING A REPLACEMENT FLEXNAV DELIVERY SYSTEM (LOT: 8813401) . THE VALVE WAS DEPLOYED AT A DEPTH OF 4MM ON THE NON-CORONARY CUSP AND 5MM ON THE LEFT CORONARY CUSP. ONCE DEPLOYED AT 100%, THE VALVE EMBOLIZED. A THIRD VALVE WAS THEN IMPLANTED WITHIN THE FIRST VIA VALVE-IN-VALVE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150926 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL NVTR-25 8824885 05415067031587

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Required Intervention