BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX VALVE

    MDR report key: 21900976 · Received April 24, 2025

    Report

    Report Number
    2025587-2025-02978
    Event Type
    Injury
    Date Received
    April 24, 2025
    Date of Event
    March 19, 2025
    Report Date
    April 24, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: FREESTYLE BIOPROSTHESIS, PRODUCT ID: 995, SERIAL NUMBER: UNKNOWN, USE BY DATE: UNKNOWN, UDI: UNKNOWN. CITATION: GOLZARIAN H, OSMAN A, KLEMAN AC, ET AL. VALVE-IN-VALVE TAVR COMPLICATED BY LEFT MAIN CORONARY OBSTRUCTION SALVAGED BY LEFT ATRIAL VA-ECMO. JACC CASE REP. 2025;30(6 PT 1):103200. DOI: 10.1016/J.JACCAS.2024.103200. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    LITERATURE WAS REVIEWED REGARDING A PATIENT WHO UNDERWENT VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN WHICH A MEDTRONIC 29 MM EVOLUT FX TRANSCATHETER VALVE WAS IMPLANTED INSIDE A MEDTRONIC 27 MM FREESTYLE SURGICAL VALVE. IN THEIR ACCOUNT OF THE CASE, THE AUTHORS DESCRIBED THAT SHORTLY AFTER EVOLUT FX DEPLOYMENT, A SUBTOTAL OBSTRUCTION OF THE LEFT CORONARY ARTERY OCCURRED DUE TO AN IMPINGED LEAFLET (EVOLUT FX FRAME PINNED A FREESTYLE LEAFLET OVER THE LEFT CORONARY OSTIUM), CAUSING HYPOTENSION AND SUSTAINED VENTRICULAR FIBRILLATION WITH CARDIAC ARREST. CONSEQUENTLY, THE HEART TEAM PERFORMED THE FOLLOWING INTERVENTIONS: CARDIOPULMONARY RESUSCITATION, DEFIBRILLATION, VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO), AND PERCUTANEOUS CORONARY INTERVENTION (DRUG-ELUTING STENT PLACEMENT). AFTER THE PROCEDURE, THE PATIENT WAS MANAGED IN THE INTENSIVE CARE UNIT AND BY POST-PROCEDURAL DAY FIVE, THE CARDIOGENIC SHOCK ¿HAD FULLY RESOLVED.¿ FROM THERE, THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY AND SUCCESSFULLY COMPLETED ONE MONTH OF CARDIAC REHABILITATION. THE AUTHORS WROTE THAT THE PATIENT CONTINUED TO DO WELL DURING TWELVE MONTHS OF FOLLOW-UP, WITH NO CARDIOPULMONARY OR NEUROLOGIC LIMITATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483718 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTFX-29

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Hospitalization| R| L SEE H11.