BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 9292503 · Received November 7, 2019

    Report

    Report Number
    2025587-2019-03413
    Event Type
    Injury
    Date Received
    November 7, 2019
    Date of Event
    November 1, 1992
    Report Date
    November 7, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P870078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MELACINI P ET AL. LONG-TERM ECHOCARDIOGRAPHIC DOPPLER MONITORING OF HANCOCK BIOPROSTHESES IN THE MITRAL VALVE POSITION. AM J CARDIOL. 1992 NOV 1;70(13):1157-63. DOI: 10.1016/0002-9149(92)90048-4. 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 A RETROSPECTIVE ANALYSIS OF THE DURABILITY OF HANCOCK PORCINE BIOPROSTHESES IN THE MITRAL POSITION USING ECHOCARDIOGRAPHY. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 1985 AND FEBRUARY 1990. THE STUDY POPULATION INCLUDED 134 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 57 YEARS), ALL WERE IMPLANTED WITH MEDTRONIC HANCOCK BIOPROSTHETIC VALVES IN THE MITRAL POSITION (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: MILD-MODERATE-SEVERE MITRAL REGURGITATION, VALVE INCOMPETENCE, MITRAL STENOSIS, LEAFLET PROLAPSE, PARAVALVULAR LEAK, CALCIFICATION, CUSPAL TEAR/PERFORATION, PANNUS FORMATION, ENDOCARDITIS, AND ELEVATED PEAK AND MEAN GRADIENTS. IT WAS REPORTED THAT 33 PATIENTS REQUIRED REOPERATION TO REPLACE THE HANCOCK VALVE BETWEEN 7 AND 18 YEARS POST IMPLANT. THE PRIMARY REASONS FOR REPLACEMENT OF THE HANCOCK VALVE WERE DYSTROPHIC CALCIFICATION, FIBROUS TISSUE OVERGROWTH, PARAVALVULAR LEAK, TEARS, AND ENDOCARDITIS. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS DIRECTLY 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
    1084264 HANCOCK AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 242

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention