BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX VALVE

    MDR report key: 21106178 · Received January 8, 2025

    Report

    Report Number
    2025587-2025-00200
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    September 7, 2023
    Report Date
    January 8, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000370701
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. IMAGE REVIEW: INTRA PROCEDURAL FLUOROSCOPIC IMAGES WERE PROVIDED FOR REVIEW OF THE EVENT DESCRIPTION ABOVE. PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. THE VALVE WAS DEPLOYED TO 80% AND DEPTH ASSESSMENT WAS PERFORMED IN THE CUSP OVERLAP VIEW. THE DEPTH AT THE NON-CORONARY CUSP (NCC) WAS APPROXIMATELY 2MM. NEXT, AN ANGIOGRAM IN A LAO VIEW WAS PERFORMED AND DEPTH AT THE LEFT CORONARY CUSP (LCC) WAS APPROXIMATELY 0MM. THERE IS EVIDENCE OF AT LEAST ONE RECAPTURE WHICH APPEARED TO HAVE BEEN PERFORMED IN THE LAO VIEW. THE DEPTH AT THE LCC WAS STILL APPROXIMATELY 0MM, BUT THE FRAME APPEARED TO BE SLIGHT DEEPER ON NCC. HOWEVER, PROPER DEPTH AT THE NCC IS ASSESSED IN THE CUSP OVERLAP VIEW AND THERE IS NO EVIDENCE THAT THIS WAS PERFORMED AFTER THE SECOND DEPLOYMENT ATTEMPT. PER MEDTRONIC BEST PRACTICES, THE TARGET DEPTH OF IMPLANTATION IS 3MM. RECAPTURE IS RECOMMENDED IF DEPTH <(><<)>1MM OR >5M M. FURTHERMORE, DEPTH ASSESSMENT AT THE NCC IS PERFORMED IN A CUSP OVERLAP VIEW, AND IF ACCEPTABLE, NEXT STEP IS TO MOVE TO THE 3-CUSP COPLANAR VIEW AND REMOVE PARALLAX FROM THE INFLOW PORTION OF THE VALVE (ROLL LAO NO GREATER THAN 25°) TO VERIFY DEPTH AT THE LCC. THE VALVE MAY BE RELEASED ONCE THESE STEPS ARE COMPLETED. THE VALVE WAS <(> <<)>1MM AT THE LCC WHICH WOULD WARRANT A RECAPTURE. HOWEVER, THE VALVE WAS RELEASED RESULTING IN AORTIC DISLODGMENT. THE DISLODGED VALVE WAS NOT SNARED, AND A NEW VALVE WAS IMPLANTED WITHIN THE DISLODGED VALVE. IT WAS REPORTED THAT A POST BALLOON AORTIC VALVULOPLASTY WAS PERFORMED THAT CONTRIBUTED TO THE DISLODGEMENT; HOWEVER, THERE IS NO EVIDENCE OF THAT IN THE FLUOROSCOPIC IMAGES. THE IMAGES REVEAL THAT A POST BALLOON VALVULOPLASTY WAS PERFORMED AFTER THE SECOND VALVE WAS IMPLANTED. A FINAL AORTOGRAM WAS PERFORMED CONFIRMING CORONARY PERFUSION AND NO PARAVALVULAR LEAK. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE INITIAL VALVE WAS DEPLOYED AFTER ONE RECAPTURE INTO THE DELIVERY CATHETER SYSTEM DUE TO AN UNKNOWN REASON. FOLLOWING DEPLOYMENT, THE VALVE DISLODGED TOWARDS THE AORTA. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED INSIDE THE ANNULUS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE IMPLANT OF THE VALVE, NO PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED AND THE VALVE WAS RECAPTURED DUE TO SHALLOW IMPLANT DEPTH. A SAFARI GUIDEWIRE WAS USED DURING THE PROCEDURE. THE DEPLOYMENT START POINT WAS AT THE BOTTOM AT AN IMPLANT DEPTH OF 2 MILLIMETER (MM) ON THE NON-CORONARY CUSP (NCC) AND 2 MM ON THE LEFT CORONARY CUSP (LCC). THE DELIVERY CATHETER SYSTEM (DCS) WAS FULLY WITH DRAWN WHEN THE VALVE DISLODGED. A POST IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED PRIOR TO THE VALVE DISLODGMENT DUE TO PARAVALVULAR LEAK (PVL). AFTER THE VALVE DISLODGED, THE IMPLANT DEPTH WAS -3 MM ON THE NCC AND 2 MM ON THE LCC. PER THE PHYSICIAN, THE PATIENT'S LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CALCIFICATION CONTRIBUTED TO THE VALVE DISLODGEMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE POST-IMPLANT BAV DISLODGED THE FIRST VALVE. THE SEVERITY OF THE PVL WAS MODERATE, AND A POST-IMPLANT BAV WAS PERFORMED FOLLOWING THE IMPLANT OF THE SECOND VALVE. THE POST-IMPLANT BAV FOLLOWING THE IMPLANT OF THE SECOND VALVE WAS PERFORMED DUE TO AN EXPANSION ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610900 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTFX-29 00763000370701

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Required Intervention