BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 12942244 · Received December 6, 2021

    Report

    Report Number
    2025587-2021-03678
    Event Type
    Injury
    Date Received
    December 6, 2021
    Date of Event
    January 1, 1989
    Report Date
    December 6, 2021
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    DYE
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: THIENE ET AL. MODE OF FAILURE OF THE HANCOCK PERICARDIAL VALVE XENOGRAFT. AM J CARDIOL. (B)(6) 1989; 63(1):129-33. DOI: 10. 1016/0002-9149(89)91099-0. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. 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 VIA LITERATURE REGARDING EXPERIENCES WITH HANCOCK PERICARDIAL BIOPROSTHETIC SURGICAL VALVES. ALL DATA WERE COLLECTED FROM A SINGLE CENTER AND COLLECTED PRIOR TO JUNE 1988 WHEN THE MANUSCRIPT WAS SUBMITTED TO THE PUBLISHER. THE STUDY POPULATION INCLUDED 18 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE( B)(6)) WHO WERE IMPLANTED WITH 22 HANCOCK VALVES IN THE AORTIC (15) OR MITRAL (7) POSITION FOR A MEAN OF 40 MONTHS. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. MORPHOLOGIC EVALUATION WAS PERFORMED ON THE EXPLANTED VALVES WHICH CONSISTED OF GROSS, X-RAY, HISTOLOGIC AND ULTRASTRUCTURAL EXAMINATIONS. NOTED ISSUES INCLUDED: CUSPAL TEARS; VALVE INCOMPETENCE; LEAFLET PROLAPSE; FIBROUS TISSUE OVERGROWTH; CALCIFICATION; STENOSIS BY CUSP STIFFENING; ENDOCARDITIS DUE TO ENTEROCOCCUS B-HEMOLYTICUS AND STREPTOCOCCUS FECALIS; PARAVALVULAR LEAK AT 16 MONTHS POST-IMPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1838280 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE HEART VALVES SANTA ANA MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Life Threatening| R