BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 5807246 · Received July 19, 2016

    Report

    Report Number
    2025587-2016-01099
    Event Type
    Injury
    Date Received
    July 19, 2016
    Date of Event
    December 20, 2015
    Report Date
    June 21, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: MID- TO LONG-TERM CLINICAL OUTCOMES OF HANCOCK II BIOPROSTHESIS IN CHINESE POPULATION CITATION: CHINESE MEDICAL JOURNAL 2015 VOLUME 128(24):3317-23 (DOI 10.4103/0366-6999.171424) AUTHORS: YIN WANG, SI CHEN, XING-JIAN HU, JIA-WEI SHI, NIAN-GUO DONG. DATE OF PUBLISH WAS USED FOR INCIDENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING THE MID- TO LONG-TERM CLINICAL PERFORMANCE OF HANCOCK II BIOPROSTHESIS IN THE CHINESE POPULATION. ALL DATA WERE COLLECTED RETROSPECTIVELY FROM A SINGLE CENTER BETWEEN JANUARY 2004 AND DECEMBER 2013. THE STUDY POPULATION INCLUDED 647 PATIENTS (PREDOMINANTLY MALE; AVERAGE AGE 61.9 ± 18.3 YEARS), ALL OF WHICH WERE IMPLANTED WITH MEDTRONIC HANCOCK AORTIC (AVR) (N=262) MITRAL (MVR) (N=311) OR BOTH AORTIC AND MITRAL (DVR) ( N=74) VALVE. SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: 21 INCIDENTS OF BLEEDING THAT REQUIRED A BLOOD TRANSFUSION (6 AVR, 12 MVR AND 3 DVR). TWENTY SIX INCIDENTS OF THROMBOEMBOLISM OCCURRED (9 AVR, 13 MVR, AND 4 DVR). EIGHT INCIDENTS OF ENDOCARDITIS (4 AVR, 3 MVR AND 1 DVR), 6 OF WHICH WERE TREATED WITH SURGICAL INTERVENTION AND 2 TREATED MEDICALLY. TWELVE INCIDENTS OF STRUCTURAL VALVE DETERIORATION OCCURRED (SVD) (4 AVR, 6 MVR, 2 DVR) ALL INCIDENTS OF SVD WERE TREATED WITH REOPERATION. OTHER ADVERSE EVENTS INCLUDED: 11 INCIDENTS OF PARAVALVULAR LEAK (PVL), (6 AVR, 4 MVR, AND 1 DVR). EIGHT OF THESE INCIDENTS WERE SEVERE AND REQUIRED REOPERATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457307 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T510

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention