BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 23118983 · Received September 22, 2025

    Report

    Report Number
    2025587-2025-05701
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    December 31, 2024
    Report Date
    September 22, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: AWAD ET AL. TRANSCATHETER VERSUS SURGICAL AORTIC VALVE REPLACEMENT IN PATIENTS WITH AORTIC STENOSIS WITH A SMALL AORTIC AN NULUS: A META-ANALYSIS WITH RECONSTRUCTED TIME TO EVENT DATA. INT J CARDIOL HEART VASC. 2024 DEC 31:56:101578. DOI: 10.1016/J.IJCHA.2024.101578.  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 META-ANALYSIS OF TRANSCATHETER VERSUS SURGICAL AORTIC VALVE REPLACEMENT IN PATIENTS WITH AORTIC STENOSIS WITH A SMALL AORTIC ANNULUS.  THE META-ANALYSIS WAS COMPRISED OF 11 CLINICAL TRIALS WHICH INCLUDED 3,670 PATIENTS.  MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION; MEDTRONIC DEVICES INCLUDED COREVALVE, EVOLUT R, EVOLUT PRO, EVOLUT PRO+, EVOLUT FX TRANSCATHETER VALVES AND MOSAIC SURGICAL VALVES. DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS.  AMONG ALL PATIENTS, CLINICAL OBSERVATIONS INCLUDED: STROKE, MODERATE TO SEVERE PARAVALVULAR LEAK (PVL), MYOCARDIAL INFARCTION (MI), ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, MAJOR VASCULAR OR BLEEDING COMPLICATION, PATIENT-PROSTHESIS MISMATCH (PPM), AND AORTIC VALVE-RELATED HOSPITALIZATION OR REINTERVENTION.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580895 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION 30519

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| R