BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX VALVE

    MDR report key: 19657040 · Received July 2, 2024

    Report

    Report Number
    2025587-2024-03765
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    June 24, 2024
    Report Date
    July 2, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000370695
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: D-EVOLUTFX-2329, PRODUCT LOT/SERIAL NUMBER: UNKNOWN, PRODUCT TYPE: 0195-HEART VALVES. POST-IMPLANT BALLOON AORTIC VALVULOPLASTY BALLOON: (MANUFACTURER: UNKNOWN). (SERIAL/LOT NUMBER: UNKNOWN). 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 IN A PATIENT WITH A PREVIOUSLY IMPL ANTED SURGICAL AORTIC VALVE (SAV), THE VALVE WAS FULLY DEPLOYED AT A DEPTH OF 0 MM ON THE NON-CORONARY CUSP (NCC) AND 2 MM ON THE LEFT CORONARY CUSP (LCC). FOLLOWING DEPLOYMENT, UNDER-EXPANSION OF THE VALVE FRAME WAS NOTED AND A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED UNDER RAPID PACING. DURING THE BAV, THE VALVE DISLODGED TO A NEW DEPTH OF -1 MM ON THE NCC AND -1 MM ON THE LCC. PER THE PHYSICIAN, THE CAUSE OF THE DISLODGEMENT WAS THE POST-IMPLANT BAV AND BECAUSE THE VALVE WAS SLIGHTLY ABOVE THE SAV FRAME AFTER FINAL RELEASE PRIOR TO THE BAV. AFTER INITIAL VALVE DISLODGEMENT, A SECOND TRANSCATHETER VALVE WAS IMPLANTED IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525929 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTFX-26 00763000370695

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention SEE H11.