BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 23708826 · Received December 3, 2025

    Report

    Report Number
    2025587-2025-05998
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    September 1, 2025
    Report Date
    December 3, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MAULER-WITTWER ET AL. EMERGENT REDO TRANSCATHETER AORTIC VALVE IMPLANTATION IN A NONAGENARIAN PATIENT WITH MULTIPLE ORGAN FAILURE. CJC OPEN. VOL 7, ISS 11, NOV 2025, P 1535-1537. DOI: 10.1016/J.CJCO.2025.08.014. PUBLISHED ONLINE SEPT 1, 2025. 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 90-YEAR-OLD FEMALE PATIENT WHO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) FOR TREATMENT OF SEVERE AORTIC STENOSIS. DURING THE IMPLANT PROCEDURE, A MEDTRONIC 29-MM EVOLUT PRO BIOPROSTHETIC VALVE DISLODGED FROM THE TARGET POSITION SHOWING MODERATE PARAVALVULAR AORTIC REGURGITATION AND A MEAN GRADIENT OF 17 MMHG. THE VALVE WAS SNARED TO ALLOW FOR ADVANCEMENT AND PLACEMENT OF A SECOND EVOLUT PRO BIOPROSTHETIC TRANSCATHETER VALVE WHICH RESULTED IN NO RESIDUAL AORTIC REGURGITATION AND MEAN GRADIENT OF 5 MMHG. APPROXIMATELY SEVEN YEARS LATER THE PATIENT PRESENTED WITH ACUTE CONGESTIVE HEART FAILURE AND PNEUMONIA. TRANSTHORACIC ECHOCARDIOGRAPHY SHOWED BIOPROSTHETIC VALVE DYSFUNCTION WITH SEVERE VALVULAR AORTIC REGURGITATION. WHILE HOSPITALIZED, THE PATIENT¿S CONDITION WORSENED AS SHE DEVELOPED MULTIPLE ORGAN FAILURE AND ACUTE RESPIRATORY DISTRESS. SUBSEQUENTLY, THE PATIENT UNDERWENT AN EMERGENT PROCEDURE WITH SUCCESSFUL IMPLANT OF A NON-MEDTRONIC TRANSCATHETER VALVE WHICH RESULTED IN NO RESIDUAL AORTIC REGURGITATION AND A MEAN GRADIENT OF 8 MMHG. TWO DAYS POST-PROCEDURE, THE PATIENT DEVELOPED COMPLETE ATRIO-VENTRICULAR ( AV) BLOCK WHICH REQUIRED IMPLANT OF A PERMANENT PACEMAKER. SEVEN DAYS LATER SHE WAS TRANSFERRED TO REHABILITATION AND AT THE SIX MONTH FOLLOW-UP SHE WAS FOUND TO BE IN GOOD CONDITION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2853442 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-29

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female Required Intervention| H| L