BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 20953865 · Received December 17, 2024

    Report

    Report Number
    2135147-2024-06430
    Event Type
    Death
    Date Received
    December 17, 2024
    Date of Event
    November 22, 2024
    Report Date
    February 6, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031600
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. AN EVENT OF DEATH, HYPOTENSION, AND CARDIAC ARREST 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 WAS REVIEWED BY AN ABBOTT SENIOR DIRECTOR OF MEDICAL AFFAIRS. BASED ON ALL AVAILABLE INFORMATION, CAUSES FOR THE REPORTED DEATH, HYPOTENSION, AND CARDIAC ARREST COULD NOT BE CONCLUSIVELY DETERMINED. THE REPORTED UNEXPECTED MEDICAL INTERVENTION WAS THE RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING, DESIGN, OR MANUFACTURING OF THE DEVICE.

    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) 2024, 29MM NAVITOR VALVE WAS SELECTED FOR IMPLANT IN AN EXTREMELY FRAGILE PATIENT. DURING THE PROCEDURE, AFTER PRE-DILATION WITH A 20MM NON-ABBOTT BALLOON, THE PATIENT EXPERIENCED A CONTINUOUS DECREASE IN BLOOD PRESSURE. THE VALVE WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. AFTER 40 MINUTES OF CARDIAC MASSAGE TO RESTORE THE PATIENT'S CONDITION, THEY ENDED UP PASSING AWAY DUE TO CARDIAC ARREST. THERE WAS NO ALLEGED CONSEQUENCES DUE TO THE ABBOTT DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, 29MM NAVITOR VALVE WAS SELECTED FOR IMPLANT IN AN EXTREMELY FRAGILE PATIENT. DURING THE PROCEDURE, AFTER PRE-DILATION WITH A 20MM NON-ABBOTT BALLOON, THE PATIENT EXPERIENCED A CONTINUOUS DECREASE IN BLOOD PRESSURE. THE VALVE WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. AFTER 40 MINUTES OF CARDIAC MASSAGE TO RESTORE THE PATIENT'S CONDITION, THEY ENDED UP PASSING AWAY DUE TO CARDIAC ARREST. THERE WAS NO ALLEGED CONSEQUENCES DUE TO THE ABBOTT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291622 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 8850971 05415067031600

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown Required Intervention| D