BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK

    MDR report key: 7576706 · Received June 7, 2018

    Report

    Report Number
    2025587-2018-01399
    Event Type
    Injury
    Date Received
    June 7, 2018
    Date of Event
    March 7, 2018
    Report Date
    June 6, 2018
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P790007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BECKERMAN Z. HIGH INCIDENCE OF LATE INFECTIVE ENDOCARDITIS IN BOVINE JUGULAR VEIN VALVED CONDUITS J THORAC CARDIOVASC SURG. 2018 APR 13. PII: S0022-5223(18)30979-6. DOI: 10.1016/J.JTCVS.2018.03.156. 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. 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 HIGH INCIDENCE OF LATE INFECTIVE ENDOCARDITIS IN BOVINE JUGULAR VEIN VALVED CONDUITS. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2001 AND 2017. THE STUDY POPULATION INCLUDED 228 PATIENTS (PREDOMINANTLY MALE; MEDIAN AGE 2 YEARS), WHO UNDERWENT INITIAL PLACEMENT OR REPLACEMENT WITH 253 MEDTRONIC CONTEGRA BOVINE JUGULAR VALVED CONDUIT. TWENTY FOUR PATIENT HAD BEEN PREVIOUSLY IMPLANTED WITH MEDTRONIC CONTEGRA BOVINE JUGULAR VALVED CONDUIT AND ONE PATIENT HAD BEEN PREVIOUSLY IMPLANTED WITH MEDTRONIC HANCOCK BIOPROSTHETIC VALVED CONDUIT. THE SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS EARLY MORTALITY WAS REPORTED IN 2 PATIENTS DUE TO HEART FAILURE ON POSTOPERATIVE DAY 1 AND DAY 10. THERE WAS NO EVIDENCE THAT THESE DEATHS WERE DEVICE RELATED. ADDITIONALLY, LATE MORTALITY WAS REPORTED IN 4 PATIENTS DUE TO: SEPTIC SHOCK DUE TO PERITONITIS AND NECROTIZING ENTEROCOLITIS, MYOCARDIAL INFARCTION (MI), AND PNEUMONIA. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: INFECTIVE ENDOCARDITIS AND CONDUIT REPLACEMENT OCCURRING AT MEDIAN OF 7.5 YEARS. BASED ON THE AVAILABLE INFORMATION, THESE ADVERSE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420054 HANCOCK HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA HC150-12

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention