BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE HANCOCK II

    MDR report key: 5973703 · Received September 23, 2016

    Report

    Report Number
    2025587-2016-01515
    Event Type
    Injury
    Date Received
    September 23, 2016
    Date of Event
    August 30, 2015
    Report Date
    September 7, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: DOES IMPLANTATION OF LARGER BIOPROSTHETIC PULMONARY VALVES IN YOUNG PATIENTS GUARANTEE DURABILITY IN ADULTS? DURABILITY ANALYSIS OF STENTED BIOPROSTHETIC VALVES IN THE PULMONARY POSITION IN PATIENTS WITH TETRALOGY OF FALLOT CITATION: EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY (2016) VOL 49(4):1207-12 DOI (10.1093/EJCTS/EZV298) AUTHORS: JAE GUN KWAK, CHEUL LEE, MINA LEE, CHANG-HA LEE, SO-ICK JANG, SANG YUN LEE, SU-JIN PARK, MI KYOUNG SONG AND SEONG-HO KIM EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT 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 FACTORS THAT AFFECT THE DURABILITY OF BIOPROSTHETIC PULMONARY VALVES WITH REGARD TO PATIENT AGE AND SIZE OF IMPLANTED VALVE. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 1998 AND 2014. THE STUDY POPULATION INCLUDED 108 PATIENTS (MEAN AGE 19.3 ± 9.1 YEARS, MEAN WEIGHT WAS 48.3 ± 14.7 KG), 39 OF WHICH WERE IMPLANTED WITH A MEDTRONIC HANCOCK II (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: 26 INCIDENTS OF VALVULAR DYSFUNCTION, WHICH WAS DEFINED AS THE PRESENCE OF MODERATE OR SEVERE REGURGITATION OR A PEAK PRESSURE GRADIENT OF =40 MMHG. REOPERATION WAS PERFORMED IN 4 PATIENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625769 VALVE HANCOCK II HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION HANCOCKII

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention