BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 9295513 · Received November 8, 2019

    Report

    Report Number
    2025587-2019-03414
    Event Type
    Injury
    Date Received
    November 8, 2019
    Date of Event
    November 1, 2000
    Report Date
    November 8, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P870078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: NIINAMI H ET AL. MALFUNCTION OF A HANCOCK BIOPROSTHESIS IN THE MITRAL POSITION 24 YEARS AFTER INITIAL IMPLANTATION. J HEART VALVE DIS. 2000 NOV;9(6):810-812. DOI: NOT AVAILABLE. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE (MONTH AND YEAR VALID). 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 THE 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. [(B)(4)].

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A (B)(6)-YEAR-OLD MALE PATIENT WITH A HISTORY OF RHEUMATIC DEGENERATION AND MITRAL STENOSIS WHO UNDERWENT MITRAL VALVE REPLACEMENT WITH A 25 MM MEDTRONIC HANCOCK BIOPROSTHETIC VALVE (SERIAL NUMBER NOT PROVIDED). IT WAS NOTED THAT THE PATIENT HAD PRE-EXISTING ATRIAL FIBRILLATION THAT PERSISTED AFTER THE VALVE REPLACEMENT PROCEDURE. AT 24 YEARS POST IMPLANT, THE PATIENT PRESENTED WITH ACUTE SHORTNESS OF BREATH (NEW YORK HEART ASSOCIATION FUNCTIONAL CLASS III) AND WAS DIAGNOSED WITH A PANSYSTOLIC MURMUR. CHEST RADIOGRAPHY SHOWED MILD CARDIOMEGALY AND TWO-DIMENSIONAL ECHOCARDIOGRAPHY REVEALED SEVERE MITRAL INSUFFICIENCY WITH AN ELEVATED MEAN PRESSURE GRADIENT ACROSS THE MITRAL HANCOCK VALVE (17.9 MMHG). IT WAS REPORTED THAT THE PATIENT¿S CONDITION IMPROVED FOLLOWING THE ADMINISTRATION OF DIURETIC AND INOTROPIC MEDICATIONS. SUBSEQUENTLY, THE PATIENT¿S CREATININE LEVEL INCREASED DUE TO THE DIURETIC TREATMENT AND HAD TO UNDERGO REDO MITRAL VALVE REPLACEMENT. THE HANCOCK VALVE WAS SUCCESSFULLY EXPLANTED AND REPLACED WITH A 29 MM NON-MEDTRONIC MECHANICAL VALVE. MACROSCOPIC AND RADIOGRAPHIC EXAMINATION OF THE EXPLANTED VALVE FOUND TWO LEAFLET PERFORATIONS, A TEAR ALONG THE COMMISSURAL ATTACHMENT, PANNUS OVERGROWTH, AND CALCIFICATION ON ALL THREE LEAFLETS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090676 HANCOCK AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 242

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention