BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXNAV DELIVERY SYSTEM

    MDR report key: 24720635 · Received March 30, 2026

    Report

    Report Number
    2135147-2026-02010
    Event Type
    Death
    Date Received
    March 30, 2026
    Date of Event
    March 3, 2026
    Report Date
    May 6, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031372
    PMA / PMN Number
    P190023
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    AN EVENT OF DIFFICULT TO ADVANCE WAS 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. ADDITIONALLY, THE LOT WAS REVIEWED FOR SIMILAR COMPLAINTS, AND THERE IS NO INDICATION OF A LOT-SPECIFIC PRODUCT ISSUE. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED ADVANCEMENT ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. IT IS POSSIBLE PROCEDURAL AND/OR PATIENT CIRCUMSTANCES CONTRIBUTED TO THE REPORTED ADVANCEMENT DIFFICULTY; HOWEVER, THIS CANNOT BE CONFIRMED. THE REPORTED UNEXPECTED MEDICAL INTERVENTIONS ARE DUE TO CASE SPECIFIC CIRCUMSTANCES, AS A CPR WAS PERFORMED AND MEDICATION WAS PROVIDED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM (DS). PRIOR TO THE PROCEDURE, THE PATIENT WAS IN A STABLE CONDITION. THE PATIENT HAD SEVERE CALCIFIED ANATOMY IN THE ASCENDING AND ABDOMINAL AORTA. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 17MM, NON-ABBOTT BALLOON. DURING THE PROCEDURE, THE DS WAS UNABLE TO ADVANCE THE SINOTUBULAR JUNCTION (STJ) CALCIUM DEPOSITS, SO IT WAS RETRACTED DOWN TO THE ABDOMINAL AORTA. DURING THE TIME OF DISCUSSION ON CONTINUING WITH THE NEXT STEPS, THE PATIENT BECAME HYPOTENSIVE AND A CARDIOPULMONARY RESUSCITATION (CODED) WAS PERFORMED, AND MEDICATION (UNSPECIFIED) WAS ADMINISTERED, SUBSEQUENTLY THE PATIENT WAS PRONOUNCED TO BE DECEASED. THE PHYSICIAN STATED THAT HE DOES NOT BELIEVE IT WAS A PRODUCT ISSUE OTHER THAN NOT BEING ABLE TO CROSS CALCIFIED STJ. ADDITIONALLY, HE STATED THAT THE ADVERSE CONSEQUENCES WERE DUE TO PATIENT'S ANATOMY, FRAILTY, AND BEING HIGH RISK FOR THE PROCEDURE. THE OFFICIAL CAUSE OF DEATH WAS CIRCULATORY COLLAPSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2026, A 25 MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM (DS). PRIOR TO THE PROCEDURE, THE PATIENT WAS IN A STABLE CONDITION. THE PATIENT HAD SEVERE CALCIFIED ANATOMY IN THE ASCENDING AND ABDOMINAL AORTA. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 17 MM, NON-ABBOTT BALLOON. DURING THE PROCEDURE, THE DS WAS UNABLE TO ADVANCE THE SINOTUBULAR JUNCTION (STJ) CALCIUM DEPOSITS, SO IT WAS RETRACTED DOWN TO THE ABDOMINAL AORTA. DURING THE TIME OF DISCUSSION ON CONTINUING WITH THE NEXT STEPS, THE PATIENT BECAME HYPOTENSIVE AND A CARDIOPULMONARY RESUSCITATION (CODED) WAS PERFORMED, AND MEDICATION (UNSPECIFIED) WAS ADMINISTERED, SUBSEQUENTLY THE PATIENT WAS PRONOUNCED TO BE DECEASED. THE PHYSICIAN STATED THAT HE DOES NOT BELIEVE IT WAS A PRODUCT ISSUE OTHER THAN NOT BEING ABLE TO CROSS CALCIFIED STJ. ADDITIONALLY, HE STATED THAT THE ADVERSE CONSEQUENCES WERE DUE TO PATIENT'S ANATOMY, FRAILTY, AND BEING HIGH RISK FOR THE PROCEDURE. THE OFFICIAL CAUSE OF DEATH WAS CIRCULATORY COLLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127523 FLEXNAV DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL FNAV-DS-SM 10902420 05415067031372

    Patients

    Seq Age Sex Outcome Treatment
    1