BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 19934454 · Received August 7, 2024

    Report

    Report Number
    2025587-2024-04495
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    June 19, 2024
    Report Date
    August 7, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HARTLEY ET AL. EMBOLISM AND INVERSION OF A TAVR PROSTHESIS IN A DILATED ASCENDING AORTA. JACC CARDIOVASC INTERV. 2024 JUL 22;17(14):1735-1737. DOI: 10.1016/J.JCIN.2024.05.010. EPUB 2024 JUN 19. 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 73-YEAR-OLD FEMALE PATIENT WITH SYMPTOMATIC SEVERE AORTIC STENOSIS WHO UNDERWENT IMPLANT OF A MEDTRONIC 26-MM EVOLUT PRO+ BIOPROSTHETIC VALVE.  AFTER RELEASE FROM THE DELIVERY CATHETER SYSTEM, THE BIOPROSTHETIC VALVE DISLODGED FROM THE TARGETED POSITION INTO THE ASCENDING AORTA.  THE DISLODGED VALVE WAS SNARED WHILE A SECOND BIOPROSTHETIC VALVE (MANUFACTURER OR MODEL NOT PROVIDED) WAS SUCCESSFULLY IMPLANTED WITH GOOD RESULTS.  ONCE THE SNARE WAS RELEASED COMPUTED TOMOGRAPHY SHOWED THE DISLODGED VALVE INVERTED AND ON TOP OF THE SUCCESSFULLY IMPLANTED SECOND VALVE.  ECHOCARDIOGRAPHY DEMONSTRATED NO INCREASE IN VALVULAR GRADIENTS.  THE POST-PROCEDURAL RECOVERY WAS UNEVENTFUL FOR THE PATIENT.  AT THE 6-MONTH FOLLOW-UP THE PATIENT WAS NOTED AS ASYMPTOMATIC WITH STABLE TRANSPROSTHETIC GRADIENTS.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026810 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-26US

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention| L| H