BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX VALVE

    MDR report key: 22904103 · Received August 27, 2025

    Report

    Report Number
    9617601-2025-01194
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    August 22, 2025
    Report Date
    September 2, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    UDI-DI
    00763000597962
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID L-EVOLUTFX-2329 (LOT: 0012617232); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE PRODUCT ID D-EVOLUTFX-2329 (LOT: 0012585685); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID D-EVOLUTFX-2329 (LOT: 0012585685); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE PRODUCT ID L-EVOLUTFX-2329 (LOT: 0012617232); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVFXPLUS-26 (K032332); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE 2025-08-22; EXPLANT DATE 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

    UPDATED: B1, B5, D6B, H6. 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 DURING A TRANSCATHETER AORTIC VALVE PROCEDURE, THE VALVE SHIFTED AND MOVED UP UPON RELEASE HOWEVER WAS NOT COMPLETELY DISLODGED. A SECOND VALVE WAS DEPLOYED WITHIN THE MALPOSITIONED VALVE, AND AN ATTEMPT WAS MADE TO INSERT AND INFLATE A BALLOON WITHIN THE SECOND VALVE, BUT THE BALLOON COULD NOT BE ADVANCED PAST THE MALPOSITIONED VALVE CROWNS. THE PROCEDURE WAS ABORTED, AND THE PATIENT REQUIRED SURGICAL INTERVENTION LATER IN THE DAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE PROCEDURE, THE VALVE SHIFTED AND MOVED UP UPON RELEASE HOWEVER WAS NOT COMPLETELY DISLODGED. A SECOND VALVE WAS DEPLOYED WITHIN THE MALPOSITIONED VALVE, AND AN ATTEMPT WAS MADE TO INSERT AND INFLATE A BALLOON WITHIN THE SECOND VALVE, BUT THE BALLOON COULD NOT BE ADVANCED PAST THE MALPOSITIONED VALVE CROWNS. THE PROCEDURE WAS ABORTED, AND THE PATIENT REQUIRED SURGICAL INTERVENTION LATER IN THE DAY. ADDITIONAL INFORMATION WAS RECEIVED THAT A PRE-IMPLANT BALLOON DILATION WAS PERFORMED. THE PATIENT ANATOMY CONTRIBUTED TO THE DISLODGEMENT DUE TO A CALCIUM NODULE UNDER RIGHT CORONARY CUSP (RCC) AND THE NON-CORONARY CUSP (NCC) WHICH EXTENDED INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). THE SECOND VALVE WAS IMPLANTED BUT A POST-IMPLANT BALLOON DILATION WAS REQUIRED DUE TO SIGNIFICANT PARAVALVULAR LEAK (PVL). THE FIRST AND SECOND VALVE WERE EXPLANTED AND REPLACED WITH A SURGICAL AORTIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467885 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUTFX-26 00763000597962

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention