BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 12845036 · Received November 19, 2021

    Report

    Report Number
    2025587-2021-03509
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    May 1, 2021
    Report Date
    November 19, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: LIU K, ET AL. INVESTIGATION OF FAILURE MODES OF EXPLANTED PORCINE VALVES IN THE MITRAL POSITION. J THORAC DIS. 2021 MAY;13 (5):2858-2866. DOI: 10.21037/JTD-20-3578. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT: MAY 1, 2021 (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 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 · 0

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE MORPHOLOGICAL AND PATHOLOGICAL FEATURES OF DETERIORATED PORCINE MITRAL VALVES AFTER EXPLANTATION. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN SEPTEMBER 2018 AND DECEMBER 2019. THE STUDY POPULATION INCLUDED 12 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 55 YEARS; MEAN WEIGHT 62.4 KG). ALL PATIENTS HAD A DETERIORATED PORCINE MITRAL VALVE EXPLANTED AND EXAMINED TO DETERMINE THE FAILURE MODES AND DAMAGE CHARACTERISTICS. OF THE EXPLANTED VALVES, 5 WERE MEDTRONIC HANCOCK II PORCINE MITRAL VALVES. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. THE MEAN IMPLANT DURATION FOR THE HANCOCK II VALVES WAS 7.75 YEARS (RANGE, 4.25 TO 12 YEARS). AMONG THE EXPLANTED HANCOCK II VALVES, THE AUTHORS OBSERVED THE FOLLOWING TYPES OF DYSFUNCTION: CUSP TEARS, COMMISSURAL DEHISCENCE, CALCIFICATION, PANNUS FORMATION, MITRAL REGURGITATION, AND COMBINED MITRAL REGURGITATION/MITRAL STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746470 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION T510

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention| H