BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 21440230 · Received February 21, 2025

    Report

    Report Number
    2025587-2025-01389
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    February 5, 2025
    Report Date
    February 21, 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
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: BHASTANA ET AL. TRANSCATHETER AORTIC VALVE REPLACEMENT FOR DEGENERATIVE BIOPROSTHETIC MOSAIC VALVE. J AM COLL CARDIOL CASE REP. 2025 FEB, 30 (3) 103124. DOI: 10.1016/J.JACCAS.2024.103124. 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 75-YEAR-OLD MALE PATIENT WHO UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) FOR A DEGEN ERATIVE MOSAIC SURGICAL BIOPROSTHETIC VALVE. NEARLY TWENTY YEARS PRIOR, THE PATIENT WAS IMPLANTED WITH A MEDTRONIC 23-MM MOSAIC SURGICAL VALVE TO TREAT AORTIC DEGENERATIVE STENOSIS, AND AFTER DEVELOPING ATRIOVENTRICULAR BLOCK ALSO RECEIVED A DUAL-CHAMBER PACEMAKER IN THAT SAME YEAR. MORE RECENTLY THE PATIENT PRESENTED WITH CONGESTIVE CARDIAC FAILURE. ECHOCARDIOGRAPHY SHOWED A SEVERELY DEGENERATED SURGICAL VALVE WITH A MEAN GRADIENT OF 50 MMHG AND MILD AORTIC REGURGITATION. IN VIEW OF HIS HIGH SURGICAL RISK STATUS, A VA LVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT (VIV-TAVR) WAS PLANNED. IN THE PROCEDURE, A MEDTRONIC EVOLUT R TRANSCATHETER VALVE WAS PLACED INSIDE OF THE MOSAIC SURGICAL VALVE; HOWEVER, POST-DEPLOYMENT MEASUREMENTS SHOWED HIGH GRADIENTS AND MODERATE PARAVAL VULAR LEAK. DURING ATTEMPTED BALLOON DILATION, THE VALVE EMBOLIZED OUT OF POSITION. SUBSEQUENTLY, A SECOND MEDTRONIC EVOLUT R TRANSCATHETER VALVE WAS IMPLANTED INSIDE THE MOSAIC SURGICAL VALVE. POST-DEPLOYMENT MEASUREMENTS SHOWED ¿PERSISTENT GRADIENTS¿ ACROSS THE VALVE, WHICH WERE RESOLVED BY A BALLOON DILATION. HEMODYNAMICS MEASUREMENTS SHOWED NO GRADIENTS, AND AORTIC ROOT ANGIOGRAM SHOWED NO PARAVALVULAR LEAK AND PATENT CORONARIES. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED THAT THE FLUOROSCOPIC MARKERS ON THE MOSAIC SURGICAL VALVE ARE ON THE STENT POSTS AND NOT THE ANNULAR RING, MAKING THE POSITIONING OF THE TRANSCATHETER AORTIC VALVE CHALLENGING, AND LED TO MALPOSITIONING OF THE FIRST ATTEMPTED TRANSCATHETER VALVE. THE PHYSICIAN/AUTHOR ALSO REPORTED THAT ADEQUATE TRAINING AND UNDERSTANDING THE ANATOMY OF VALVES CAN OVERCOME THIS ISSUE, AS THEY STATED "IT WASN¿T THE PROBLEM ABOUT THE MOSAIC VALVE BEING FAULTY IN ANYWAY, BUT ITS DESIGN IN GENERAL". NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268948 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R