BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 17230293 · Received June 29, 2023

    Report

    Report Number
    2135147-2023-02863
    Event Type
    Death
    Date Received
    June 29, 2023
    Date of Event
    April 28, 2023
    Report Date
    July 19, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031587
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF VASCULAR DISSECTION, ARRHYTHMIA, AND PATIENT DEATH TWO DAYS AFTER THE IMPLANT PROCEDURE WAS REPORTED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. INFORMATION FROM THE FIELD INDICATED NO PERFORMANCE RELATED TO THE NAVITOR DEVICE WAS REPORTED. BASED ON THE MEDICAL REVIEW, "THE REVIEW IS BASED ON THE INFORMATION PROVIDED WHICH DOES NOT INCLUDE IMAGING OR IMAGING REPORTS. THE PATIENT¿S TYPE A AORTIC DISSECTION WAS A PROCEDURAL COMPLICATION WHICH OCCURRED AFTER NAVITOR IMPLANT FROM SUBCLAVIAN APPROACH (L OR R NOT SPECIFIED IN THE INFORMATION PROVIDED). THE DISSECTION WAS MOST LIKELY DUE TO TRAUMA TO THE AORTIC WALL EITHER FROM THE GORE DRYSEAL SHEATH OR FROM THE NAVITOR DELIVERY SYSTEM; THE NAVITOR VALVE IS LESS LIKELY TO HAVE CAUSED THE DISSECTION BUT CANNOT BE COMPLETELY EXCLUDED. THE DISSECTION REPORTEDLY LED TO A CASCADE OF EVENTS INCLUDING VF ARREST; DESPITE URGENT MECHANICAL SUPPORT, THE PATIENT DID NOT SURVIVE." BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM NAVITOR VALVE WAS SELECTED FOR AN IMPLANT. THERE WAS NO CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. THE PROCEDURE WAS PERFORMED THROUGH THE SUBCLAVIAN ARTERY APPROACH AND THE DEVICE WAS IMPLANTED WITH AN IMPLANT DEPTH OF NON-CORONARY CUSP OF 2MM. LEFT CORONARY CUSP OF 3MM. IT WAS NOTED THAT A TYPE A DISSECTION OCCURRED FROM THE OSTIUM OF THE ASCENDING AORTA TO THE OSTIUM OF THE SUBCLAVIAN ARTERY. IT WAS THOUGHT THE DISSECTION OCCURRED DUE TO AN 18 FR NON ABBOTT DRY SEAL FLEX INTRODUCER SHEATH DURING PRE-BALLOON VALVULOPLASTY (PREBAV), HOWEVER THIS COULD NOT BE VERIFIED. NO TREATMENT WAS CONDUCTED FOR THE TYPE A DISSECTION. VENTRICULAR FAILURE DEVELOPED SHORTLY BEFORE PATIENT¿S CONDITION DETERIORATED. ORIGINALLY, THE PATIENT'S LEFT ANTERIOR DESCENDING ARTERY (LAD) AND LEFT CIRCUMFLEX ARTERY (LCX) ALSO HAD CORONARY ARTERY STENOSIS. IT WAS UNKNOWN IF THERE WERE ANY COMPLICATION DUE TO THE PLACEMENT OF THE NAVITOR THIS TIME. IT WAS NOTED THAT DURING THE PROCEDURE A SHEATH WAS INSERTED IN THE LOWER LIMB FOR PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) OR INTRA-AORTIC BALLOON PUMP (IABP) AT THE TIME THERE WAS A SUDDEN CHANGE IN THE PATIENT'S HEMODYNAMICS. THE PATIENT PASSED AWAY DUE TO ARRHYTHMIA ON THE (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS EVENT WAS PREVIOUSLY REPORTED IN RELATED MANUFACTURER REFERENCE NUMBER: 2135147-2023-02761 BUT WILL NOW BE CAPTURED HERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527675 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL NVTR-25 8850969 05415067031587

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death