BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 20398584 · Received October 8, 2024

    Report

    Report Number
    2025587-2024-05569
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    November 30, 2023
    Report Date
    October 8, 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
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: SAZZAD F, TAN YK, CHAN LXB, ET AL. SYSTEMATIC REVIEW OF FIRST IN-HUMAN AND EARLY PHASE CLINICAL TRIALS FOR SURGICALLY IMPL ANTABLE BIOLOGICAL MITRAL VALVE SUBSTITUTES. J CARDIOTHORAC SURG. 2023;18(1):348. PUBLISHED 2023 NOV 30. DOI:10.1186/S13019-023-02464-2 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: HANCOCK II (PRODUCT CODE DYE, PMA# P980043), INTACT (NOT FDA APPROVED), MOSAIC (PRODUCT CODE DYE, PMA# P990064). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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 SYSTEMATIC REVIEW OF FIRST IN-HUMAN AND PRELIMINARY CLINICAL TRIALS FOR SURGICALLY IMPLANTABLE BIOLOGICAL MITRAL VALVES. TWENTY-TWO STUDIES WERE INCLUDED IN THE REVIEW. MEDTRONIC (HANCOCK II, INTACT, MOSAIC) AND NON-MEDTRONIC (VARIOUS) VALVE BRANDS WERE IMPLANTED IN THE POOLED STUDY POPULATION OF 3,332 PATIENTS. EARLY AND LATE DEATHS OCCURRED IN THE STUDY POPULATION. THERE WAS NO EVIDENCE PRESENTED TO SUGGEST A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. THE AUTHORS ALSO ANALYZED THE FOLLOWING POST-IMPLANT OUTCOMES: HIGH MEAN/PEAK GRADIENTS, REOPERATION, STRUCTURAL VALVE DETERIORATION, THROMBOEMBOLISM, BLEEDING, ENDOCARDITIS, AND PERIPROSTHETIC LEAK. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22550 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R