BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXNAV DELIVERY SYSTEM

    MDR report key: 23069103 · Received September 16, 2025

    Report

    Report Number
    2135147-2025-05235
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 22, 2025
    Report Date
    November 19, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031372
    PMA / PMN Number
    P190023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT RETURNING FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF RETRACTION PROBLEM 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, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE REPORTED RETRACTION PROBLEM COULD NOT BE CONCLUSIVELY DETERMINED. 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 AUGUST 22, 2025, A 25MM NAVITOR WAS SELECTED CHOSEN FOR IMPLANTATION, UTILIZING AN SMALL FLEXNAV DELIVERY SYSTEM (DS). DURING DEVICE PREPARATION, THERE WAS NO ISSUES RETRACTING THE DEVICE INTO THE DELIVERY SYSTEM, AND NO ISSUES LEADING THE RETAINER TABS INTO THE RETAINER RECEPTACLE. HOWEVER, DURING THE FIRST TIME OF RE-SHEATHING, DIFFICULTIES RETRACTING THE VALVE COMPLETELY INTO THE CAPSULE OCCURRED. THE VALVE WAS NEVER RE-SHEATHED MORE THAN TWO TIMES. A SMALL GAP REMAINED OF 2MM. TO CLOSE THE GAP, THE MICRO ADJUSTMENT WHEEL WAS USED UNTIL SAFELY PULLED INTO THE DESCENDING AORTA FOR SAFE RETRIEVAL. FOLLOWING THE GUIDELINES OF RECAPTURING, 90% OF THE VALVE WAS RECAPTURED AND RETRIEVED OUTSIDE THE PATIENT WITHOUT CAUSING ANY INJURIES TO THE AORTIC ARCH NOR TO THE FEMORAL ARTERY. THE CAPSULE WAS SQUEEZED AT THE PROXIMAL PART OF THE DS. A NEW DS AND VALVE WERE LOADED, AND THE VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED TO BE STABLE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT DISCHARGED IN VERY GOOD CONDITION.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270082 FLEXNAV DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL FNAV-DS-SM 10667990 05415067031372

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female