BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 9157477 · Received October 4, 2019

    Report

    Report Number
    2025587-2019-03044
    Event Type
    Injury
    Date Received
    October 4, 2019
    Date of Event
    November 1, 2006
    Report Date
    October 4, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BOTTIO T ET AL. COMMISSURAL DEHISCENCE: A RARE AND PECULIAR CAUSE OF PORCINE VALVE STRUCTURAL DETERIORATION. J THORAC CARDIOVASC SURG. 2006 NOV;132(5):1017-22. DOI: 10.1016/J.JTCVS.2006.06.012. 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. 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 AN EXAMINATION THE RATE AND MODE OF OCCURRENCE OF COMMISSURAL DEHISCENCE IN FIRST- AND SECOND-GENERATION PORCINE BIOPROSTHETIC VALVE EXPLANTS. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 1970 AND JANUARY 2004. THE STUDY ANALYZED 586 EXPLANTED BIOPROSTHESES. PATIENT DEMOGRAPHICS: PREDOMINANTLY FEMALE WITH A MEAN AGE OF 65 YEARS. OF THE EXPLANTED VALVES, 455 WERE MEDTRONIC HANCOCK STANDARD (104 AORTIC POSITION, 338 MITRAL POSITION, 13 TRICUSPID POSITION) AND 31 WERE MEDTRONIC HANCOCK II (6 AORTIC POSITION, 24 MITRAL POSITION, 1 TRICUSPID POSITION). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL HANCOCK STANDARD AND HANCOCK II PATIENTS, ADVERSE EVENTS INCLUDED: REOPERATION DUE TO STRUCTURAL VALVE DETERIORATION (MOSTLY A RESULT OF DYSTROPHIC CALCIFICATION), VALVE REPLACEMENT DUE TO VALVE INCOMPETENCE CAUSED BY COMMISSURAL DEHISCENCE (OBSERVED WITH HANCOCK STANDARD AND HANCOCK II MITRAL RECIPIENTS), CALCIFICATION/CALCIFIC DEPOSITS, AND VALVE ¿TEARS AND WEARS.¿ FOR ALL HANCOCK STANDARD AND HANCOCK II RECIPIENTS, VALVE EXPLANTATION OCCURRED AT A MEAN TIME OF 10 YEARS POST IMPLANT. 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
    949643 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION T505

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention