BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 20306925 · Received September 25, 2024

    Report

    Report Number
    2025587-2024-05352
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    December 23, 2023
    Report Date
    September 26, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: GLASER ET AL. PROSTHETIC VALVE ENDOCARDITIS AFTER AORTIC VALVE REPLACEMENT WITH BOVINE VERSUS PORCINE BIOPROSTHESES. JOURNAL OF THE AMERICAN HEART ASSOCIATION 13:E031387 2024. DOI: 10.1161/JAHA.123.031387.  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.

    Additional Manufacturer Narrative · 0

    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 PROSTHETIC VALVE ENDOCARDITIS AFTER AORTIC VALVE REPLACEMENT WITH BOVINE-BASED VERSUS PORCINE-BASED BIOPROSTHESES. THE STUDY POPULATION INCLUDED 21,022 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 73 YEARS OLD.  MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 1,628 PATIENTS WERE IMPLANTED WITH A MEDTRONIC MOSAIC OR HANCOCK BIOPROSTHETIC VALVE.  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, ADVERSE EVENTS INCLUDED: PROSTHETIC VALVE ENDOCARDITIS.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED THAT MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE OBSERVED ADVERSE EVENTS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233670 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization| L