BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 20738011 · Received November 20, 2024

    Report

    Report Number
    2025587-2024-06695
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    November 20, 2023
    Report Date
    November 20, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. IMAGE REVIEW: TWO STATIC IMAGES WERE PROVIDED FOR REVIEW. PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. THE IMAGES PROVIDED SHOWS A DEPLOYED VALVE THAT APPEARS TO BE UNDER EXPANDED AT THE LEVEL OF THE INFLOW, POSSIBLY DUE TO CALCIFICATION. THE UNDER EXPANSION MOST LIKELY CONTRIBUTED TO THE MODERATE PARAVALVULAR LEAK REPORTED. A POST BALLOON AORTIC VALVULOPLASTY WAS PERFORMED. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE (J040703 - PLI 10), THE VALVE WAS PREPARED AND LOADED. THE VALVE WAS INSERTED AND ATTEMPTED TO BE DEPLOYED. FOLLOWING THE FIRST DEPLOYMENT ATTEMPT, INFOLDING WAS NOTED AFTER THE FOURTH NODE. INFOLD OCCURRED AFTER AN ATTEMPT TO RECAPTURE OF THE VALVE. THE INFOLD WAS A RESULT OF A MISLOAD, AND OF NOTE, THE "FLUSH" WAS DUE TO A NEW VALVE LOADER. THE VALVE WAS REMOVED FROM THE BODY. THE ENTIRE SYSTEM WAS REPLACED. THE REPLACEMENT VALVE (J041692) WAS LOADED ONTO A REPLACEMENT DELIVERY CATHETER SYSTEM (DCS). THE VALVE WAS SUCCESSFULLY DEPLOYED AT A DEPTH OF 1 MM. AFTER REVIEWING THE ECHOCARDIOGRAM, MODERATE PARAVALVULAR LEAK (PVL) WAS IDENTIFIED. A POST IMPLANT DILATION WAS PERFORMED WITH A 20X40 NON-MEDTRONIC CRYSTAL BALLOON. THE CASE CONCLUDED WITH A MEAN GRADIENT OF 9 MMHG, AND A NORMAL ELECTROCARDIOGRAM (ECG). THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ¿FLUSH¿ WAS DUE TO A NEW VALVE LOADER REFERS TO THE VALVE LOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139263 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-26

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female