BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 20189700 · Received September 11, 2024

    Report

    Report Number
    2025587-2024-05084
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    September 3, 2024
    Report Date
    September 11, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000365677
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME EVOLUT FX VALVE; PRODUCT ID EVOLUTFX-29 (SERIAL: J051872); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO CALCIFICATION. FOLLOWING THE BAV, VALVE DEPLOYMENT WAS ATTEMPTED; HOWEVER, THE VALVE DISLODGED TO THE ASCENDING AORTA PRIOR TO COMPLETE RELEASE. THE VALVE WAS RECAPTURED INTO THE DELIVERY CATHETER SYSTEM (DCS). A SECOND DEPLOYMENT ATTEMPT WAS MADE AT A TARGET IMPLANT DEPTH OF 3-5 MM, BUT AN INFOLD IN THE VALVE FRAME WAS OBSERVED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED INTO THE DCS AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. A NEW VALVE WAS LOADED INTO A NEW DCS AND SUCCESSFULLY IMPLANTED INTO THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510969 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-2329 0012117257 00763000365677

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female SEE H11...