BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 18722518 · Received February 16, 2024

    Report

    Report Number
    2135147-2024-00721
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    January 25, 2024
    Report Date
    March 12, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031587
    PMA / PMN Number
    P190023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 UNDER EXPANSION WAS REPORTED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, AND THE PRODUCT MET ALL SPECIFICATIONS, INCLUDING SPECIFICATION FOR RADIAL FORCE. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS WAS NOT RETURNED FOR ANALYSIS. HOWEVER, A MEDICAL REVIEW OF IMAGING RECEIVED FROM THE FIELD WAS PERFORMED AND REVEALED THAT THE PATIENT'S ANATOMY WAS BORDERLINE BETWEEN A 25MM AND A 27MM VALVE. THE CT REPORT ALSO SHOWED HEAVY CALCIUM ON ALL OF THE LEAFLETS. BASED ON THE IMAGING AND INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT CONCLUSIVELY BE DETERMINED BUT COULD BE DUE TO DUE TO CALCIUM BUILD UP ON THE PATIENT'S NATIVE VALVE WHICH MAY EXPLAIN WHY THE VALVE APPEARED UNDER EXPANDED UNTIL THE PHYSICIAN REPEATED A PRE-BAV WITH A LARGER BALLOON SIZE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM NAVITOR VALVE (SERIAL: (B)(6)) WAS CHOSEN FOR IMPLANTATION UTILIZING A SMALL FLEXNAV DELIVERY SYSTEM (LOT: 8983283). THE PATIENT'S SINUS OF VALSALVA (SOV) DIAMETER WAS WELL BELOW RECOMMENDED SIZE FOR 27MM VALVE. VALVE DIMENSIONS WERE 73.3MM PERIMETER, 412.5MM AREA. THE PATIENT PRESENTED WITH A SEVERELY CALCIFIED NATIVE VALVE. A PRE-IMPLANT BALLOON VALVULOPLASTY (BAV) WAS PERFORMED WITH A 19MM BALLOON. THE VALVE WAS ADVANCED TO THE ANNULUS AND AT 80% DEPLOYMENT THE NAVITOR SEEMED TO BE UNDER EXPANDED. THE NAVITOR WAS RECAPTURED AND REMOVED FROM THE PATIENT SO A 22MM BALLOON COULD BE USED TO PRE-DILATED THE NATIVE VALVE AGAIN. AFTER DILATATION, THE SAME 25MM NAVITOR WAS ATTEMPTED TO BE IMPLANTED HOWEVER, AT 80% DEPLOYMENT IT APPEARED UNDER EXPANDED AND A "FLAT" PORTION AT 12 O'CLOCK IN SHORT AXIS VIEW OF ANNULAR PORTION OF VALVE. THE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT. A REPLACEMENT 25MM NAVITOR VALVE (SERIAL: (B)(6)) AND SMALL FLEXNAV DELIVERY SYSTEM (LOT:8983283) WAS THEN ATTEMPTED TO BE IMPLANTED HOWEVER, AFTER DEPLOYMENT AND ASSESSMENT UNDER FLUOROSCOPY AND ECHOCARDIOGRAM IT WAS DETERMINED THAT THE VALVE WAS NOT MAKING FULL ANNULAR CONTACT. THERE WAS NO MALFUNCTION WITH THIS VALVE AND IT WAS THOUGHT IT WAS A MIS-SIZING. A REPLACEMENT 27MM NAVITOR (SERIAL: (B)(6)) WAS THEN IMPLANTED SUCCESSFULLY UTILIZING A LARGE FLEXNAV DELIVERY SYSTEM (LOT: 8919755). THERE WERE NO PATIENT CONSEQUENCES AND NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THE PATIENT WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431266 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 8998073 05415067031587

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SMALL FLEXNAV DELIVERY SYSTEM