BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 20421675 · Received October 10, 2024

    Report

    Report Number
    2025587-2024-05643
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    August 23, 2023
    Report Date
    October 10, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: RAGHEB ET AL. SHORT- AND MID-TERM RESULTS OF PULMONARY VALVE REPLACEMENT WITH THE INSPIRIS VALVE. THE ANNALS OF THORACIC SURGEONS. AUGUST 23, 2023; 117(6):1203-1210. DOI: 10.1016/J.ATHORACSUR.2023.07.049. 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 SHORT- AND MID-TERM RESULTS OF PULMONARY VALVE REPLACEMENT WITH THE INSPIRIS VALVE. THE STUDY POPULATION INCLUDED 225 PATIENTS WITH A MEAN AGE OF 16 YEARS OLD WHO WERE PREDOMINANTLY FEMALE. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 163 PATIENTS WERE IMPLANTED WITH A MEDTRONIC MOSAIC 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 MOSAIC BIOPROSTHETIC VALVE PATIENTS, ADVERSE EVENTS INCLUDED: PULMONARY VALVE REPLACEMENT, TRANSCATHETER PULMONARY VALVE REPLACEMENT OR VALVE-IN-VALVE REPLACEMENT AND RIGHT VENTRICLE OUTFLOW TRACT (RVOT) OBSTRUCTION; MALFUNCTIONS INCLUDED: PULMONARY STENOSIS, MILD, MODERATE AND SEVERE PULMONARY REGURGITATION AND HIGH GRADIENTS OF THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006139 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION 30519

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Life Threatening| H| R