BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 12412892 · Received September 2, 2021

    Report

    Report Number
    2025587-2021-02725
    Event Type
    Injury
    Date Received
    September 2, 2021
    Date of Event
    March 4, 2021
    Report Date
    September 2, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KANG, Y ET AL. COMPARATIVE ANALYSIS OF STRUCTURAL VALVE DETERIORATION AFTER BIOPROSTHETIC TRICUSPID VALVE REPLACEMENT: BOVINE PERICARDIAL VERSUS PORCINE VALVES. ARTIFICIAL ORGANS. 2021; 45:911-918. DOI: 10.1111/AOR.13909. EARLIEST DATE OF PUBLISH 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. 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 STRUCTURAL VALVE DYSFUNCTION (SVD) AFTER THE IMPLANT OF A BOVINE OR PORCINE PERICARDIAL BIOPROSTHETIC SURGICAL TRICUSPID VALVE. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN 1996 AND 2018. THE STUDY POPULATION INCLUDED 134 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 61 YEARS), 20 OF WHOM WERE IMPLANTED WITH MEDTRONIC HANCOCK II SURGICAL VALVE. THE REMAINING PATIENTS WERE IMPLANT WITH A NON-MEDTRONIC BOVINE PERICARDIAL VALVE (108) OR A NON-MEDTRONIC PORCINE PERICARDIAL VALVE (6). SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS IMPLANTED WITH A PORCINE PERICARDIAL SURGICAL VALVE, ADVERSE EVENTS INCLUDED: REGURGITATION, CEREBRAL VASCULAR ACCIDENT (CVA), MEDIASTINITIS AND BLEEDING THAT REQUIRED RE-INTERVENTION. BASED ON THE AVAILABLE INFORMATION A 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
    1311763 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T510

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R