BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 17951055 · Received October 17, 2023

    Report

    Report Number
    2135147-2023-04560
    Event Type
    Death
    Date Received
    October 17, 2023
    Date of Event
    September 27, 2023
    Report Date
    December 12, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031600
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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, SNARING OF THE VALVE AGAINST THE INSTRUCTIONS FOR USE, DISSECTION OF THE AORTA AND PATIENT DEATH WAS REPORTED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. THE EVENT AND TWO IMAGES WERE REVIEWED BY ABBOTT MEDICAL AFFAIRS. THE REVIEW FOUND THAT AN APPROPRIATELY SIZED VALVE WAS CHOSEN FOR THE ANNULAR MEASUREMENT. THERE WAS ADEQUATE CALCIUM. HOWEVER, THE ASCENDING AORTA MEASUREMENT WAS GREATER WHAT IS RECOMMENDED FOR THE 29 MM VALVE. THE MAIN REASON FOR THE EMBOLIZATION WAS INTERACTION OF THE DELIVERY SYSTEM WITH THE NAVITOR AFTER DEPLOYMENT. ADDITIONAL FACTORS WHICH CONTRIBUTED TO THE EMBOLIZATION INCLUDED THE FACT THAT THE VALVE WAS DEPLOYED AT 1 MM AND THAT A LARGER THAN RECOMMEND AORTA FOR THE VALVE SIZE. DURING SNARING OF THE FIRST VALVE AND PULL BACK THERE WAS LIKELY INJURY TO THE AORTA, HOWEVER, THERE WAS ALSO INTERACTION BETWEEN THE SECOND NAVITOR AND THE FIRST (EMBOLIZED) DEVICE WHICH THE REPORTING PHYSICIANS FELT WAS THE MAIN CAUSE OF THE DISSECTION. THERE WAS NO CLEAR EVIDENCE OF MALFUNCTION OF THE DEVICE. THE CAUSE OF DEATH WAS RELATED TO THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING. IT WAS REPORTED THAT THE VALVE WAS SNARED. PER THE 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."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM NAVITOR VALVE ((B)(6)) WAS CHOSEN FOR IMPLANT USING A FLEXNAV DELIVERY SYSTEM (8890746) DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION. IT WAS REPORTED THE NATIVE VALVE'S MEASUREMENTS WERE AS FOLLOWS: PERIMETER=79.2MM, AORTIC ANNULUS (AA) DIAMETER MIN=22.5MM, AA DIAMETER MAX=27.8MM, AND AA DIAMETER AVERAGE=25.2MM. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. THE VALVE WAS OPENED IN A HIGH POSITION AT 0MM TO +1MM. THE IMPLANT DEPTH AT DEPLOYMENT WAS +1MM AND THE IMPLANT DEPTH AT RELEASE WAS +1MM. IT WAS REPORTED THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING AND THERE WAS TENSION IN THE DELIVERY SYSTEM AT THE TIME OF FINAL DEPLOYMENT. IT WAS CONFIRMED VIA IMAGING THAT ALL THREE RETAINER TABS HAD RELEASED PRIOR TO REMOVAL OF THE DELIVERY SYSTEM. THERE WERE NO DIFFICULTIES IN DEPLOYING OR RETRACTING THE VALVE AND THE VALVE WAS NEVER RESHEATHED MORE THAN TWO TIMES. DURING REMOVAL OF THE DELIVERY SYSTEM, THE DELIVERY SYSTEM TOUCHED AND PULLED UP THE VALVE, CAUSING IT TO MIGRATE A FEW CENTIMETERS INTO THE ASCENDING AORTA. THE MIGRATED VALVE DID NOT REMAIN WITHIN THE AORTIC ANNULUS AND DID NOT BLOCK A CORONARY ARTERY. THE DECISION WAS MADE TO SNARE THE DEVICE INTO THE UPPER AORTA. A SECOND 29MM NAVITOR VALVE ((B)(6)) WAS CHOSEN FOR IMPLANT USING A NEW FLEXNAV DELIVERY SYSTEM (8872816). DURING THE DEPLOYMENT OF THE SECOND VALVE WHILE NAVIGATING THROUGH THE FIRST VALVE, THE TIP OF THE SECOND DELIVERY SYSTEM TOUCHED THE FIRST VALVE AND MAY HAVE CREATED PRESSURE OF THE FIRST VALVE ON THE DISTAL END OF THE AORTA. THE SECOND VALVE WAS POSITIONED AND FULLY IMPLANTED. HOWEVER, IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE DECREASED, AND INTERNAL BLEEDING WAS DETECTED. RESUSCITATION WAS STARTED, AND THE PATIENT WAS SENT TO OPEN HEART SURGERY. IT WAS NOTED THAT THERE WAS AN AORTIC DISSECTION, WHICH WAS ATTEMPTED TO BE REPAIRED DURING SURGERY. IT WAS REPORTED THE CAUSE OF THE AORTIC DISSECTION WAS ATTRIBUTED TO THE INTERACTION BETWEEN THE SECOND DELIVERY SYSTEM AND THE FIRST VALVE. THE PATIENT DIED DUE TO MAJOR BLEEDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM NAVITOR VALVE (19535741) WAS CHOSEN FOR IMPLANT USING A FLEXNAV DELIVERY SYSTEM (8890746) DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION. IT WAS REPORTED THE AORTIC VALVE ANNULUS HAD PERIMETER 79.2MM, MINIMUM DIAMETER 22.5MM, DIAMETER MAXIMUM 27.8MM, AND DIAMETER AVERAGE 25.2MM. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. THE VALVE WAS OPENED IN A HIGH POSITION AT 0MM TO +1MM. THE STARTING IMPLANT DEPTH AT DEPLOYMENT WAS +1MM, AND THE FINAL IMPLANT DEPTH AT RELEASE WAS +1MM. IT WAS REPORTED THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING, AND THERE WAS TENSION IN THE DELIVERY SYSTEM AT THE TIME OF FINAL DEPLOYMENT. IT WAS CONFIRMED VIA IMAGING THAT ALL THREE RETAINER TABS HAD RELEASED PRIOR TO REMOVAL OF THE DELIVERY SYSTEM. THERE WERE NO DIFFICULTIES IN DEPLOYING OR RETRACTING THE VALVE, AND THE VALVE WAS NEVER RE-SHEATHED MORE THAN TWO TIMES. DURING REMOVAL OF THE DELIVERY SYSTEM, THE DELIVERY SYSTEM TOUCHED AND PULLED UP THE VALVE, CAUSING IT TO MIGRATE A FEW CENTIMETERS INTO THE ASCENDING AORTA. THE MIGRATED VALVE DID NOT REMAIN WITHIN THE AORTIC ANNULUS AND DID NOT BLOCK A CORONARY ARTERY. THE DECISION WAS MADE TO SNARE THE DEVICE INTO THE UPPER AORTA. A SECOND 29MM NAVITOR VALVE (19544235) WAS CHOSEN FOR IMPLANT USING A NEW FLEXNAV DELIVERY SYSTEM (8872816). DURING THE DEPLOYMENT OF THE SECOND VALVE WHILE NAVIGATING THROUGH THE FIRST VALVE, THE TIP OF THE SECOND DELIVERY SYSTEM TOUCHED THE FIRST VALVE AND MAY HAVE CREATED PRESSURE OF THE FIRST VALVE ON THE DISTAL END OF THE AORTA. THE SECOND VALVE WAS POSITIONED AND FULLY IMPLANTED. HOWEVER, IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE DECREASED, AND INTERNAL BLEEDING WAS DETECTED. RESUSCITATION WAS STARTED, AND THE PATIENT WAS SENT TO OPEN HEART SURGERY. IT WAS NOTED THAT THERE WAS AN AORTIC DISSECTION, WHICH WAS ATTEMPTED TO BE REPAIRED DURING SURGERY. IT WAS REPORTED THE CAUSE OF THE AORTIC DISSECTION WAS ATTRIBUTED TO THE INTERACTION BETWEEN THE SECOND DELIVERY SYSTEM AND THE FIRST VALVE. THE PATIENT DIED DUE TO MAJOR BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89603 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 8816700 05415067031600

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Death