BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXNAV DELIVERY SYSTEM

    MDR report key: 23439762 · Received October 31, 2025

    Report

    Report Number
    2135147-2025-06293
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    October 8, 2025
    Report Date
    December 12, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067031389
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF ADVANCEMENT DIFFICULTY THROUGH PATIENT ANATOMY AND INSERTION DIFFICULTIES INTO PATIENT 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 DIFFICULTY COULD NOT BE CONCLUSIVELY DETERMINED. THE REPORTED BLEEDING MAY HAVE RESULTED AS A DOWNSTREAM CONSEQUENCE OF THE REPORTED HEART BLOCK. THE REPORTED INTERVENTIONS WERE A RESULT OF CASE-SPECIFIC CIRCUMSTANCES, AS PERMANENT PACEMAKER IMPLANTED FOR HEART BLOCK. 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) 2025, A 29MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAD A PRIOR MEDICAL HISTORY OF AORTIC STENOSIS BUT NO HISTORY OF CARDIAC CONDUCTION DISORDERS. THE BASELINE RHYTHM WAS NOTED TO BE NORMAL SINUS RHYTHM. THE LENGTH OF THE MEMBRANOUS SEPTUM WAS 3.6MM. THERE WAS CALCIFICATION BELOW THE ANNULUS BUT NOT IN THE INTRAVENTRICULAR SEPTUM PLANE. DURING THE PROCEDURE, THE PRIMARY AND SECONDARY ACCESS SITES WERE IDENTIFIED AS THE RIGHT FEMORAL ARTERY (RFA) AND LEFT FEMORAL ARTERY (LFA), RESPECTIVELY. A PIGTAIL CATHETER WAS POSITIONED VIA THE LFA, WHILE A TEMPORARY PACING WIRE WAS INTRODUCED THROUGH THE LEFT FEMORAL VEIN (LFV). A 14 FRENCH INTRODUCER SHEATH WAS INSERTED, FOLLOWED BY A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 22 MM NON-ABBOTT BALLOON. AFTER THE BALLOON WAS EXCHANGED FOR THE DS, IT INITIALLY ENCOUNTERED RESISTANCE AT THE VESSEL ENTRY POINT BEFORE EVENTUALLY ENTERING. AS ADVANCEMENT CONTINUED, THE DEVICE GOT HUNG UP AT THE COMMON ILIAC. THE DEPLOYMENT WHEEL WAS GRADUALLY ROTATED TO RETRACT THE CAPSULE, ALLOWING FOR A REATTEMPT AT ADVANCEMENT, WHICH THEN PROCEEDED SMOOTHLY. THE VALVE WAS DEPLOYED AT 7MM DEPTH ON BOTH THE NON-CORONARY CUSP (NCC) AND LEFT-CORONARY CUSP (LCC) WITH ONE RECAPTURE. AFTER REMOVING THE DS, THE PRIMARY SITE WAS CLOSED WITH 2 PERCLOSE DEVICES. DURING THIS IT WAS NOTED THAT THE PATIENT WAS IN LEFT BUNDLE BRANCH BLOCK (LBBB) BUT HAD A STABLE RHYTHM AND BLOOD PRESSURE. IT WAS THEN NOTED THAT THE PRIMARY SITE WAS BLEEDING CONTINUOUSLY SO RFA WAS ACCESSED BY GOING UP AND OVER FROM THE LFA AND PLACED A NON-ABBOTT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AND INFLATED IT FOR FIVE MINUTES. A DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOT SHOWED A SMALL BLOOD LEAK THEN THE BALLOON WAS PLACED AGAIN AND INFLATED IT FOR ANOTHER TEN MINUTES FOR THE BLEEDING TO STOP. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. A PERMANENT PACEMAKER WAS IMPLANTED AS AN INTERVENTION TO TREAT THE HEART BLOCK. THE PATIENT HAD A PROLONGED HOSPITAL STAY FOR MONITORING OF RHYTHM. THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084938 FLEXNAV DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL FNAV-DS-LG 10965513 05415067031389

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention 14 F INTRODUCER SHEATH.| FNAV-DS-LG.| NVRO-29.