BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR VISION

    MDR report key: 20207059 · Received September 12, 2024

    Report

    Report Number
    2135147-2024-04463
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    August 19, 2024
    Report Date
    October 10, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067045775
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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

    IT WAS REPORTED THAT DURING IMPLANTATION THE PATIENT SUFFERED A NON-FATAL STROKE. IT WAS TOO LATE TO ABORT THE PROCEDURE, SO THE VALVE WAS IMPLANTED SUCCESSFULLY. THE PATIENT WAS SENT TO NEUROLOGY FOR TREATMENT. THE DEVICE REMAINS IMPLANTED AND WILL NOT RETURN TO ABBOTT FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, AND THE PRODUCT MET ALL SPECIFICATIONS. REQUESTS WERE MADE FOR ADDITIONAL PROCEDURAL DETAILS SURROUNDING THE CASE (E.G., OPERATIVE NOTES, PROCEDURE IMAGING), HOWEVER THIS INFORMATION WAS NOT SUPPLIED BY THE SITE. BASED ON THE LIMITED INFORMATION AVAILABLE, THE CAUSE OF REPORTED STROKE COULD NOT BE CONCLUSIVELY DETERMINED. INFORMATION FROM FIELD INDICATED THAT THE STROKE OCCURRED DUE TO SEVERE CALCIFICATION IN THE FEMORAL/ILIAC ARTERIES. 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 29MM NAVITOR VISION TRANSCATHETER AORTIC VALVE (SERIAL:(B)(6) WAS CHOSEN FOR IMPLANTATION UTILIZING A LARGE FLEXNAV DELIVERY SYSTEM (LOT: 1032288). DURING IMPLANTATION, THE PATIENT SUFFERED A NON-FATAL STROKE. IT WAS TOO LATE TO ABORT THE PROCEDURE, SO THE VALVE WAS IMPLANTED SUCCESSFULLY. PATIENT WAS SENT TO NEUROLOGY FOR TREATMENT. IT WAS THOUGHT THE STROKE OCCURRED DUE TO SEVERE CALCIFICATION IN THE FEMORAL/ILIAC ARTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516675 NAVITOR VISION AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 10048980 05415067045775

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Hospitalization LARGE FLEXNAV DELIVERY SYSTEM