BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX PLUS VALVE

    MDR report key: 22804568 · Received August 14, 2025

    Report

    Report Number
    9617601-2025-00970
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 12, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    UDI-DI
    00763000920425
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5 (SECOND PARAGRAPH); D4 (EXPIRATION DATE, SERIAL #, UDI #); AND H6. THE ADDITIONAL INFORMATION RECEIVED SHOWS THAT EVENT INVOLVING THE DEVICE IN THIS REPORT (SECOND VALVE, SN (B)(6)) DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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

    CONTINUATION OF D10: PRODUCT ID D-EVOLUTFX-2329 (LOT: 0012773228); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE PRODUCT ID EVFXPLUS-26 (K127627); PRODUCT TYPE: 0195-HEART VALVES. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS.  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: SIX MEDIA IMAGES AND ONE STILL IMAGE FOR THE EVENT DESCRIPTION WERE PROVIDED. THERE WAS NO EXECUTIVE SUMMARY OR COMPUTED TOMOGRAPHY (CT) PROVIDED FOR ANATOMICAL CONSIDERATIONS. A FLUOROSCOPY VALVE LOAD INSPECTION WAS PROVIDED AND IS A GOOD LOAD. IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF THIS 26MM EVOLUTFX+ VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED USING A 20 MM BALLOON. UPON DEPLOYMENT, UNDER-EXPANSION OF THE VALVE FRAME WAS OBSERVED. THE VALVE WAS RECAPTURED AND RE-DEPLOYED, BUT THE ISSUE PERSISTED. AFTER A SECOND RECAPTURE, THE DECISION WAS MADE TO REMOVE THE VALVE. A SECOND VALVE WAS LOADED BUT THERE IS NO EVIDENCE OF THE SECOND VALVE INSPECTION. IT WAS REPORTED THAT A SECOND BAV WAS PERFORMED USING A 20 MM BALLOON. A SECOND VALVE WAS DEPLOYED AND EVIDENCE SHOWS THE VALVE IS BETTER EXPANDED IN THE ANATOMY. A POST-IMPLANT BAV WAS PERFORMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. UPDATED H.6 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

    IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF THIS 26MM EVOLUTFX+ VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED USING A 20 MM BALLOON. UPON DEPLOYMENT, UNDER-EXPANSION OF THE VALVE FRAME WAS OBSERVED. THE VALVE WAS RECAPTURED AND RE-DEPLOYED, BUT THE ISSUE PERSISTED. AFTER A SECOND RECAPTURE, THE DECISION WAS MADE TO REMOVE THE VALVE. A SECOND VALVE WAS LOADED. A SECOND BAV WAS PERFORMED USING A 20 MM BALLOON. THE NEW VALVE OPENED MUCH BETTER COMPARED TO THE FIRST. A POST-IMPLANT BAV WAS PERFORMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED WHICH CLARIFIED THAT THE SECOND VALVE FULLY EXPANDED UPON DEPLOYMENT AND THE SUBSEQUENT POST-IMPLANT DILATION WAS PERFORMED BECAUSE OF MILD PARAVALVULAR LEAK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF THIS 26MM EVOLUTFX+ VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED USING A 20 MM BALLOON. UPON DEPLOYMENT, UNDER-EXPANSION OF THE VALVE FRAME WAS OBSERVED. THE VALVE WAS RECAPTURED AND RE-DEPLOYED, BUT THE ISSUE PERSISTED. AFTER A SECOND RECAPTURE, THE DECISION WAS MADE TO REMOVE THE VALVE. A SECOND VALVE WAS LOADED. A SECOND BAV WAS PERFORMED USING A 20 MM BALLOON. THE NEW VALVE OPENED MUCH BETTER COMPARED TO THE FIRST. A POST-IMPLANT BAV WAS PERFORMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955612 EVOLUT FX PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVFXPLUS-26 00763000920425

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female