BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK

    MDR report key: 8724411 · Received June 21, 2019

    Report

    Report Number
    2025587-2019-02011
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    June 1, 2000
    Report Date
    August 1, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P870078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CITATION: HOMANN M. RECONSTRUCTION OF THE RVOT WITH VALVED BIOLOGICAL CONDUITS: 25 YEARS EXPERIENCE WITH ALLOGRAFTS AND XENOGRAFTS. EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY, JUNE 2000; 17(6):624-630. HTTPS://DOI.ORG/10.1016/S1010-7940(00)00414-0. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. 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 THE LONG-TERM DURABILITY AND EXPERIENCE IN USING ALLOGRAFT AND XENOGRAFT VALVED CONDUITS FOR RIGHT-VENTRICULAR OUTFLOW GRAFT (RVOT) RECONSTRUCTION OVER A 25-YEAR PERIOD. ALL DATA WERE COLLECTED FROM A RETROSPECTIVE REVIEW AT A SINGLE CENTER BETWEEN JANUARY 1974 AND AUGUST 1999. THE STUDY POPULATION INCLUDED 505 PATIENTS, DIVIDED INTO TWO GROUPS WITH 235 PATIENTS WITH A CONDUIT DIAMETER <(><<)> 18 MM (MEDIAN AGE 9 MONTHS) AND 270 PATIENTS WITH A CONDUIT DIAMETER = 18 MM (MEDIAN AGE 7.4 YEARS). OF THESE 505 PATIENTS, 174 WERE IMPLANTED WITH MEDTRONIC HANCOCK BIOPROSTHETIC VALVED CONDUITS (NO SERIAL NUMBERS PROVIDED). AMONG ALL HANCOCK CONDUIT PATIENTS, 30-DAY MORTALITY WAS 9.6%, WITH 10-YEAR SURVIVAL BEING 67% IN THIS PATIENT POPULATION. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL MEDTRONIC HANCOCK CONDUIT PATIENTS, ADVERSE EVENTS INCLUDED: NEED FOR CONDUIT REPLACEMENT DUE TO STENOSIS/SCLEROSIS AND CALCIFICATION, TRICUSPID VALVE INCOMPETENCE, REDUCED RIGHT VENTRICULAR FUNCTION, AND PRESSURE GRADIENTS ACROSS THE RVOT ABOVE 50 MMHG. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN 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
    517164 HANCOCK HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION HC150-12

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention