BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVITOR VISION

    MDR report key: 20182581 · Received September 10, 2024

    Report

    Report Number
    2135147-2024-04419
    Event Type
    Death
    Date Received
    September 10, 2024
    Date of Event
    August 16, 2024
    Report Date
    November 13, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067045782
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 HYPOTENSION AND PATIENT DEATH WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED WAS NOT RETURNED FOR ANALYSIS. POSSIBLE CONTRIBUTING FACTORS AFTER A PORTICO VALVE IMPLANT INCLUDE PATIENT CONDITIONS, SUCH AS PRE-EXISTING ARRHYTHMIA, ANATOMICAL FACTORS, SUCH AS CALCIFICATION EXTENDING BENEATH AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM, AND THE DEPTH OF IMPLANT OF THE DEVICE. THE FINAL IMPLANT DEPTH WAS 0 MM AT NON-CORONARY CUSP AND 2 MM ON THE LEFT CORONARY CUSP WHICH WAS NOT DEAP ENOUGH AS INTENDED WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENT BUT COULD NOT BE CONFIRMED. NO OTHER INFORMATION WAS RECEIVED ON CONTRIBUTING FACTORS. 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, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE. FROM MEDICAL REVIEW : THE CAUSE OF DEATH IS NOT KNOWN AT THIS TIME. POSSIBILITIES INCLUDE ASCENDING AORTA DISSECTION, VALVE MIGRATION AND POSSIBLE CORONARY OBSTRUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM NAVITOR VISON VALVE WAS CHOSEN FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. THE VALVE WAS SUCCESSFULLY IMPLANTED THROUGH LEFT SUBCLAVIAN ACCESS WITH NO ISSUES PRESENT AT TIME OF DELIVERY. THE FINAL IMPLANT DEPTH WAS 0MM AT NON-CORONARY CUSP AND 2MM ON THE LEFT CORONARY CUSP. LATER THE ANESTHESIA BEGAN TO WEAN PATIENT OFF OF SEDATION, PATIENT WAS UNRESPONSIVE AND HAD NO BLOOD PRESSURE. CODE WAS CALLED AND AFTER ATTEMPTS WERE MADE TO STABILIZE PATIENT, THEY WERE UNSUCCESSFUL. PATIENT SUFFERED A SPIRAL DISSECTION OF THE ASCENDING AORTA AND SUBSEQUENTLY PASSED AWAY. THE PHYSICIAN MENTIONED THE CAUSE OF DEATH WAS RELATED TO PROCEDURE AND PATIENT COMORBIDITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON 16 AUGUST 2024, A 25MM NAVITOR VISON VALVE WAS CHOSEN FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. THERE WAS NO CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. DURING PROCEDURE, THE FEMORAL ACCESS WAS NOT VIABLE, IT WAS ATTEMPTED FROM THE LEFT SIDE, BUT AFTER MANY ATTEMPTS, THE LEFT ILIAC BECAME DISSECTED AND THEY ABANDONED THAT ACCESS SITE. THEY HAD DIFFICULTY USING THE PERCUTANEOUS NEEDLE WITH ULTRASOUND-GUIDED ACCESS TO SUCCESSFULLY ENGAGE THE ARTERY AND PASS A WIRE THROUGH BUT THE VALVE WAS SUCCESSFULLY IMPLANTED THROUGH LEFT SUBCLAVIAN ACCESS WITH NO ISSUES PRESENT AT TIME OF DELIVERY. THERE WAS NO DIFFICULTIES NOTED WHILE IMPLANTING THE DEVICE OR REPOSITIONING AND THERE WERE NO RECAPTURES. THE FINAL IMPLANT DEPTH WAS 0MM AT NON-CORONARY CUSP AND 2MM ON THE LEFT CORONARY CUSP. LATER THE ANESTHESIA BEGAN TO WEAN OFF, PATIENT WAS UNRESPONSIVE AND HAD NO BLOOD PRESSURE. CODE WAS CALLED AND AFTER ATTEMPTS WERE MADE TO STABILIZE PATIENT, THEY WERE UNSUCCESSFUL. PATIENT SUFFERED A SPIRAL DISSECTION OF THE ASCENDING AORTA AND SUBSEQUENTLY PASSED AWAY. THE EXACT CAUSE OF THE DISSECTION WAS UNKNOWN. THE CAUSE OF DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226245 NAVITOR VISION AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 10092098 05415067045782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death