BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX VALVE

    MDR report key: 20169545 · Received September 9, 2024

    Report

    Report Number
    2025587-2024-05027
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 6, 2024
    Report Date
    September 16, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000370718
    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

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT CHANGED THE EVENT DESCRIPTION AND DEVICE RELATEDNESS OF THIS PREVIOUSLY REPORTED EVENT. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. 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.

    Additional Manufacturer Narrative · 0

    IMAGE REVIEW: INTRA PROCEDURAL FLUOROSCOPIC IMAGES WERE PROVIDED FOR REVIEW. FLUOROSCOPIC VALVE LOAD INSPECTION WAS PERFORMED, AND THE OVERLAP APPEARS TO REACH JUST PRIOR TO NODE 4, WHICH WOULD BE CONSIDERED A GOOD LOAD. OVERLAP PRIOR TO NODE 4 IS CONSIDERED A GOOD LOAD; OVERLAP AT NODE 4 AND BEYOND IS CONSIDERED A MISLOAD. IT WAS REPORTED THAT AN INFOLD OCCURRED DURING THE FIRST DEPLOYMENT ATTEMPT. HOWEVER, IMAGES OF THE INFOLD WERE NOT CAPTURED THUS IT IS NOT POSSIBLE TO COMMENT ON THE INFOLDING EVENT. THE INFOLD IS CHARACTERIZED BY AN INWARD FOLD OR CREASE IN THE VALVE, EXTENDING FROM THE INFLOW. INFOLDING COULD OCCUR DUE A MISLOADED VALVE, ANATOMICAL CHARACTERISTICS SUCH AS CALCIUM, AND RECAPTURES. IF AN INFOLD IS IDENTIFIED, THE VALVE SHOULD BE RECAPTURED, REMOVED FROM THE BODY, AND NOT USED. NEW STERILE COMPONENTS MUST BE USED. EVIDENCE SUPPORTS THAT THE FIRST VALVE WAS NOT DEPLOYED, AND A NEW VALVE WAS USED FOR THE IMPLANT. A FLUOROSCOPIC VALVE LOAD INSPECTION OF THE NEW VALVE WAS PERFORMED AND CONFIRMED A GOOD LOAD. A PRE BALLOON AO RTIC VALVULOPLASTY WAS PERFORMED. THE NEW VALVE WAS DEPLOYED JUST PRIOR TO THE POINT OF NO RECAPTURE AND A DEPTH ASSESSMENT WAS PERFORMED. THE DEPTH WAS APPROXIMATELY 1-2MM ON THE NON-CORONARY CUSP (NCC) IN THE CUSP OVERLAP VIEW, AND <(><<)>1MM ON THE LEFT CORONARY CUSP (LCC) IN THE LEFT ANTERIOR OBLIQUE (LAO) VIEW. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), THE RECOMMENDED TARGET DEPTH IS 3 MM RELATIVE TO THE VALVE ANNULUS. IF THE IMPLANT DEPTH IS =1 MM OR >5 MM, CONSIDER RECAPTURE. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND REDEPLOYED IN THE LAO VIEW AT A DEPTH 3MM ON THE LCC. DEPTH REASSESSMENT IN THE CUSP OVERLAP VIEW WAS NOT PERFORMED THUS DEPTH ON THE NCC AFTER THE SECOND DEPLOYMENT WAS NOT CONFIRMED PRIOR TO RELEASE. AFTER RELEASE, THE VALVE APPEARED TO BE SLIGHTLY DEEPER AND PARAVALVULAR LEAK WAS NOTED. A POST IMPLANT DILATATION WAS PERFORMED WHICH SEEMED TO HAVE VISUALLY RESOLVED THE PARAVALVULAR LEAK. THE PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. MEDTRONIC HAS REQUESTED ADDITIONAL INFORMATION PERTAINING TO THIS REPORTABLE EVENT. IF ADDITIONAL REPORTABLE INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE IMPLANT OF THE SECOND VALVE (J163044), MILD PARAVALVULAR LEAK (PVL) WAS OBSERVED AND THE VALVE WAS RECAPTURED AS IT WAS TOO DEEP. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED DUE TO CALCIFICATION. SUBSEQUENTLY, THE VALVE WAS INSERTED INTO THE PATIENT AND DEPLOYED AT A DEPTH OF APPROXIMATELY 3-5 MM. UPON INITAL DEPLOYMENT, AN INFOLD WAS OBSERVED IN THE VALVE FRAME. THE VALVE WAS WITHDRAWN FROM THE PATIENT. A NEW VALVE WAS IMPLANTED IN THE PATIENT RESULTING IN A 5-MINUTE PROCEDURAL DELAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555963 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTFX-34 00763000370718

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male