BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT FX VALVE

    MDR report key: 19228101 · Received May 2, 2024

    Report

    Report Number
    2025587-2024-02715
    Event Type
    Death
    Date Received
    May 2, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 2, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000370695
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: L-EVOLUTFX-2329; PRODUCT TYPE: COMPRESSION LOADING SYSTEM (CLS) PRODUCT ID: D-EVOLUTFX-2329; PRODUCT TYPE: DELIVERY CATHETER SYSTEM (DCS). 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 DEVICE WAS INSPECTED PRIOR TO USE AND NO PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. THE VALVE (B)(6) WAS DEPLOYED ONCE TO 80%, AT A DEPTH OF 2MM ON THE NON-CORONARY CUSP (NCC) AND 3-4MM ON THE LEFT CORONARY CUSP (LCC). CONTRAST WAS INJECTED AND BOTH THE LEFT CORONARY ARTERY (LCA) AND RIGHT CORONARY ARTERY (RCA) FILLED. THE TEAM DECIDED TO RELEASE THE VALVE. ONCE RELEASED, THE VALVE SLIGHTLY DISLODGED AORTIC TO ABOUT 0MM ON THE NCC AND LCC. THE NCC PIG TAIL CATHETER FOR CONTRAST INJECTIONS WAS PINNED BEHIND THE VALVE UPON RELEASE, THEREFORE A J WIRE WAS INSERTED TO SAFELY REMOVE THE PIG TAIL CATHETER. AT THE SAME TIME, THE VALVE DISLODGED FURTHER CORTICALLY INTO THE SINUSES, CAUSING AN OCCLUSION IN THE RCA DUE TO THE SHALLOW DEPTH OF IMPLANT. THE PATIENT WAS STABLE, AND IMAGING WITH CONTRAST, X-RAY AND ECHOCARDIOGRAM WERE PERFORMED. THE TEAM DECIDED TO SNARE THE VALVE TO PULL IT BACK AWAY FROM THE CORONARIES. ONCE THE VALVE WAS SNARED BACK, THE PRESSURE CONTINUED TO TREND DOWN. THE PATIENT DEVELOPED ARRHYTHMIAS, THEREFORE CARDIOPULMONARY RESUSCITA TION (CPR) AND CARDIOVERSION WERE STARTED, LASTING FOR 40 MINUTES. CARDIAC MONITORING AND MEDICATION WERE ALSO USED. IN THE MEANTIME, A SECOND VALVE (B)(6) AND DELIVERY CATHETER SYSTEM (DCS) WERE PREPARED IN CASE A SECOND VALVE NEEDED TO BE DELIVERED. HOWEVER, THE PATIENT WAS UNABLE TO RECOVER FROM THE ISCHEMIA CAUSED BY RCA OCCLUSION. NO CARDIAC MOTION WAS NOTED ON ECHOCARDIOGRAM, AND THE PATIENT PASSED AWAY FROM CARDIAC ARREST CAUSED BY ISCHEMIA. PER THE PHYSICIAN, THERE WAS A CAUSAL RELATIONSHIP BETWEEN THE DEATH AND THE DEVICE AND PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438313 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTFX-26 00763000370695

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Life Threatening| R| D SEE H11.