BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 20051044 · Received August 23, 2024

    Report

    Report Number
    2135147-2024-04148
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 23, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031570
    PMA / PMN Number
    P190023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF THE VALVE NOT FULLY EXPANDING AND IMPROPER OR INCORRECT PROCEDURE OR METHOD WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IT WAS INDICATED THAT THE DURING IMPLANT THE DEVICE HAD A NON-UNIFORM EXPANSION. IT WAS ALSO NOTED THAT THE DEVICE WAS RE-SHEATHED AND RE-DEPLOYED 3 TIMES BUT MAINTAINED A NUE. 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 VALVE UNDER EXPANDING COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE. PER THE INSTRUCTIONS FOR USE, "DO NOT RE-SHEATH THE VALVE MORE THAN TWO TIMES PRIOR TO FINAL VALVE RELEASE. ADDITIONAL RE-SHEATH ATTEMPTS MAY COMPROMISE PRODUCT PERFORMANCE." INFORMATION FROM THE FIELD INDICATED THAT MORE THAN 2 RE-SHEATHS WERE PERFORMED. SINCE FIELD IS AWARE OF IFU NOT FOLLOWED LETTER WILL NOT BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 23MM NAVITOR TRANSCATHETER AORTIC VALVE WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A SMALL FLEXNAV DELIVERY SYSTEM. THE MINIMUM DIAMETER OF THE AORTIC ANNULUS WAS MEASURED AS 17.6MM AND THE MAXIMUM DIAMETER WAS 20.1MM. AN 18MM NON-ABBOTT BALLOON WAS USED FOR PRE-DILATION. DURING IMPLANT THE DEVICE HAD A NON-UNIFORM EXPANSION (NUE). THE DEVICE WAS RE-SHEATHED AND RE-DEPLOYED 3 TIMES BUT MAINTAINED A NUE. THE DEVICE WAS REMOVED FROM THE PATIENT. A 20MM NON-ABBOTT BALLOON WAS USED TO PRE-DILATE THE VALVE AGAIN. A NEW 23MM NAVITOR TRANSCATHETER AORTIC VALVE AND SMALL FLEXNAV DELIVERY SYSTEM WERE USED. THE SECOND VALVE WAS IMPLANTED AFTER 1 RE-SHEATH. THERE WAS GOOD EXPANSION AND ALL 3 RETAINER TABS WERE FULLY RELEASED. THE USER BELIEVED THE EXCESSIVE CALCIUM CAUSED THE DEVICE TO EXPAND NON-UNIFORMLY. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312532 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 9064450 05415067031570

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Female SMALL FLEXNAV DS [FNAV-DS-SM, LOT: 8999976]