BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 9482203 · Received December 17, 2019

    Report

    Report Number
    2025587-2019-03799
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    August 28, 2019
    Report Date
    December 17, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MALVINDI PG ET AL. DURABILITY OF MITRAL VALVE BIOPROSTHESES: A META-ANALYSIS OF LONG-TERM FOLLOW-UP STUDIES. ANN THORAC SURG. 2019 AUG 28. PII: S0003-4975(19)31247-0. DOI: 10.1016/J.ATHORACSUR.2019.07.024. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. 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. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE LONG-TERM DURABILITY OF MITRAL VALVE BIOPROSTHESES. ALL DATA WERE COLLECTED FROM A META-ANALYSIS REVIEW OF 40 FULL-TEXT ARTICLES. THE STUDY POPULATION INCLUDED 15,215 PATIENTS WITH A MEAN AGE OF 61 YEARS. OF THOSE, 6,193 WERE IMPLANTED WITH MEDTRONIC PORCINE SURGICAL VALVES IN THE MITRAL POSITION: HANCOCK (4,829), HANCOCK II (424), AND MOSAIC (940). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL HANCOCK, HANCOCK II, AND MOSAIC PATIENTS, EARLY MORTALITY RATES WERE 10%, 8.7%, AND 3.7%, RESPECTIVELY. NO OTHER DETAILS WERE REPORTED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: REOPERATION/REDO MITRAL VALVE REPLACEMENT DUE TO STRUCTURAL VALVE DETERIORATION. THE TYPES OF DETERIORATION OBSERVED IN PORCINE VALVES: LEAFLET CALCIFICATION, LEAFLET TEARS/DEHISCENCE, AND STENOSIS. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278638 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION T510

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention