BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR VISION

    MDR report key: 20213233 · Received September 13, 2024

    Report

    Report Number
    2135147-2024-04491
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    August 21, 2024
    Report Date
    October 2, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067045799
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    AN EVENT OF VALVE MIGRATION TOWARDS THE AORTA AFTER DEPLOYMENT WAS REPORTED. A SURGICAL INTERVENTION WAS REPORTED FOR VALVE-IN-VALVE PROCEDURE AS A SECOND 25 MM NAVITOR VALVE WAS DECIDED TO BE IMPLANTED. POSSIBLE CONTRIBUTING FACTORS FOR VALVE MIGRATION ARE INTRA-PROCEDURAL DIFFICULTIES, IMPLANT DEPTH, ANNULAR CALCIUM DISTRIBUTION, AND DEPLOYMENT OR RETRACTION DIFFICULTIES. IT WAS INDICATED THAT DURING THE PROCEDURE, AT 80% DEPLOYMENT THE VALVE WAS AT 4 MM (OPTIMAL DEPTH) ON BOTH SIDES. AND ALSO INDICATED THAT THERE WAS SUFFICIENT CALCIUM TO ALLOW FOR ANCHORING AND ALL 3 TABS WERE RELEASED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND 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. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE. PLEASE NOTE THAT PER THE NAVITOR INSTRUCTIONS FOR USE, "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. LETTER WILL NOT BE SENT DUE TO REPORTED EVENT WAS NOT CAUSED BY IFU NOT FOLLOWED.

    Description of Event or Problem · 0

    IT WAS REPORTED TAT ON (B)(6) 2024, 27MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAD AN AORTIC VALVE ANGLE OF 49 DEGREES. THE SIZING OF THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WERE: PERIMETER 72.2MM, MIN/MAX/AVG: 22 X 23.7, 22.8, AREA: 411.6. A 24MM PRE-BALLOON VALVULOPLASTY WAS PERFORMED TO PREP FOR THE VALVE IMPLANT. DURING THE PROCEDURE, THE IMPLANT DEPTH OF THE DEVICE AT 80% WAS 4MM, UPON FULL RELEASE THE DEPTH WAS ALSO AT 4MM. THERE WAS SUFFICIENT CALCIUM TO ALLOW FOR ANCHORING AND ALL 3 TABS WERE RELEASED. THE IMPLANTER ENSURED THE DS WAS IN A NEUTRAL POSITION/TO SLIGHT FORWARD PRESSURE AND PULLED THE GUIDEWIRE TO A MIDVENTRICULAR POSITION TO DEFLECT NOSECONE. IMMEDIATELY AFTER FULL RELEASE, THE DEVICE EMBOLIZED INTO THE AORTA, BUT DID NOT BLOCK ANY CORONARY ARTERIES OR OTHER ARTERIES. AN ENSNARE WAS USED TO REPOSITION THE VALVE AND A 25MM NAVITOR VALVE WAS IMPLANTED. THE PATIENT BELIEVES THE CAUSE OF THE MIGRATION WAS PANNUS FORMATION ON VALVE LEAFLETS/SMALL ELLIPTICAL LEFT VENTRICULAR OUTFLOW TRACT (LVOT). THERE WAS NO ADVERSE CONSEQUENCES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS ALIVE AND WAS BEEN DISCHARGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON 21 AUG. 2024, 27MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAD AN AORTIC VALVE ANGLE OF 49 DEGREES. THE SIZING OF THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WERE: PERIMETER 72.2MM, MIN/MAX/AVG: 22 X 23.7, 22.8, AREA: 411.6. A 24MM PRE-BALLOON VALVULOPLASTY WAS PERFORMED TO PREP FOR THE VALVE IMPLANT. DURING THE PROCEDURE, THE IMPLANT DEPTH OF THE DEVICE AT 80% WAS 4MM, UPON FULL RELEASE THE DEPTH WAS ALSO AT 4MM. THERE WAS SUFFICIENT CALCIUM TO ALLOW FOR ANCHORING AND ALL 3 TABS WERE RELEASED. THE IMPLANTER ENSURED THE DS WAS IN A NEUTRAL POSITION/TO SLIGHT FORWARD PRESSURE AND PULLED THE GUIDEWIRE TO A MIDVENTRICULAR POSITION TO DEFLECT NOSECONE. IMMEDIATELY AFTER FULL RELEASE, THE DEVICE EMBOLIZED INTO THE AORTA, BUT DID NOT BLOCK ANY CORONARY ARTERIES OR OTHER ARTERIES. AN ENSNARE WAS USED TO REPOSITION THE VALVE AND A 25MM NAVITOR VALVE WAS IMPLANTED. THE PATIENT BELIEVES THE CAUSE OF THE MIGRATION WAS PANNUS FORMATION ON VALVE LEAFLETS/SMALL ELLIPTICAL LEFT VENTRICULAR OUTFLOW TRACT (LVOT). THERE WAS NO ADVERSE CONSEQUENCES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS ALIVE AND WAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263226 NAVITOR VISION AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 9238182 05415067045799

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention