BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXNAV DELIVERY SYSTEM

    MDR report key: 24338572 · Received February 13, 2026

    Report

    Report Number
    2135147-2026-00910
    Event Type
    Death
    Date Received
    February 13, 2026
    Date of Event
    January 20, 2026
    Report Date
    March 24, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031389
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF VASCULAR DISSECTION, PERICARDIAL EFFUSION, CARDIAC TAMPONADE, SHOCK AND PATIENT DEATH WERE REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PATIENT EFFECTS COULD NOT BE CONCLUSIVELY DETERMINED. IT IS POSSIBLE THAT THE PROCEDURAL CONDITIONS MAY HAVE CONTRIBUTED TO THE EVENT, HOWEVER THIS CANNOT BE CONFIRMED. THE REPORTED PATIENT DEATH WAS ATTRIBUTABLE TO PROCEDURAL COMPLICATIONS IN CONJUNCTION WITH THE PATIENT¿S UNDERLYING COMORBIDITIES. THE UNEXPECTED MEDICAL INTERVENTION IS A RESULT OF PERICARDIOCENTESIS PERFORMED FOR EFFUSION. THE SURGICAL PROCEDURE WAS PERFORMED BECAUSE THE PATIENT REQUIRED CONVERSION TO SURGERY. THERE WERE NO RELATED COMPLAINTS ASSOCIATED WITH ANY OTHER DEVICES FROM THE LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE. BASED ON MEDICAL REVIEW: AT BASELINE, THE PATIENT HAD RECENTLY DECOMPENSATED HEART FAILURE AND SEVERELY IMPAIRED LEFT VENTRICULAR FUNCTION PRIOR TO THE NAVITOR PROCEDURE. THIS IS THEREFORE A PROCEDURAL MORTALITY; MOST LIKELY RELATED TO SINUS RUPTURE FOLLOWING THE PRE-BAV. IF ADDITIONAL INFORMATION OR IMAGING BECOMES AVAILABLE, AN ADDENDUM TO THIS REVIEW WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THE DEVICE WAS REPORTEDLY DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2026, AN 27MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAD SEVERE AORTIC STENOSIS WITH SIGNIFICANT ANNULAR, LEFT VENTRICULAR OUTFLOW TRACT (LVOT), AND LEAFLET CALCIFICATION. PRIOR TO PROCEDURE, THE PATIENT WAS PRESENTED WITH ACUTE DECOMPENSATED HEART FAILURE, SEVERE ANEMIA, SEVERE LEFT VENTRICLE SYSTOLIC DYSFUNCTION. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 22 × 40, NON-ABBOTT BALLOON. DURING THE PROCEDURE AT INITIAL VALVE DEPLOYMENT, THE PHYSICIAN NOTED A SINUS OF VALSALVA (SOV) PERFORATION/RUPTURE, LIKELY DUE TO SEVERE LEAFLET CALCIFICATION IMPINGING ON THE SOV. THE VALVE WAS ABLE TO BE DEPLOYED. A PERICARDIAL EFFUSION WAS NOTED NEAR THE SINUS OF VALSALVA (SOV). THE EFFUSION WAS CIRCUMFERENTIAL, WITH THE LARGEST DIMENSION MEASURING 2CM. THE USER BELIEVES THAT THE PERICARDIAL EFFUSION WAS DUE TO SEVERE CALCIFICATION IMPINGING ON THE SOV FOLLOWING PRE-BAV. PRESENCE OF CARDIAC TAMPONADE WAS CONCLUDED BY THE PHYSICIANS; POST-IMPLANT, PERICARDIAL FLUID DRAINAGE WAS INITIATED. THE PROCEDURE WAS CONVERTED TO A SURGICAL MANAGEMENT. UNFORTUNATELY, THE PATIENT DID NOT SURVIVE THE PROCEDURE. THE CAUSE OF DEATH WAS CARDIOGENIC SHOCK. THE IMPLANTER CLASSIFIED THIS DEATH AS BEING RELATED TO THE PROCEDURE AND THE PATIENT¿S COMORBIDITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400320 FLEXNAV DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL FNAV-DS-LG 10430068 05415067031389

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Death| R NVRO-27.