BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 11992809 · Received June 14, 2021

    Report

    Report Number
    2025587-2021-01878
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    July 1, 2004
    Report Date
    June 14, 2021
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    DYE
    PMA / PMN Number
    P870078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: RUEL ET AL. LATE INCIDENCE AND DETERMINANTS OF STROKE AFTER AORTIC AND MITRAL VALVE REPLACEMENT. ANN THORAC SURG. 2004 JUL ;78(1):77-83; DISCUSSION 83-4. DOI: 10.1016/J.ATHORACSUR.2003.12.058. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC SURGICAL VALVES REFERENCED: HANCOCK I (PMA# P870078, PRODUCT CODE DYE), HANCOCK II (PMA# P980043, PRODUCT CODE DYE), INTACT (NOT APPROVED FOR US MARKET). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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 · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING LATE INCIDENCE AND DETERMINANTS OF STROKE AFTER AORTIC AND MITRAL VALVE REPLACEMENT. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 1970 AND 2002. THE OVERALL STUDY POPULATION INCLUDED 3,189 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 61.41 YEARS). AMONG THESE PATIENTS, 1,546 WERE IMPLANTED WITH A MEDTRONIC HALL MECHANICAL VALVE (N=620) OR A MEDTRONIC HANCOCK I (N=221), HANCOCK II (N=577), OR INTACT (N=128) BIOPROSTHETIC VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 97 DEATHS OCCURRED DUE TO STROKE AS A PRIMARY CAUSE. NO FURTHER DETAILS WERE PROVIDED ON THESE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATH(S). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: STROKE WITH NEUROLOGIC DEFICIT LASTING MORE THAN THREE WEEKS, MAJOR BLEEDING EVENTS REQUIRING HOSPITAL ADMISSION OR TRANSFUSION. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886697 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE HEART VALVES SANTA ANA MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R