BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 8925651 · Received August 23, 2019

    Report

    Report Number
    2025587-2019-02638
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    November 22, 2017
    Report Date
    August 23, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ROCHA R ET AL. SURGICAL ENLARGEMENT OF THE AORTIC ROOT DOES NOT INCREASE THE OPERATIVE RISK OF AORTIC VALVE REPLACEMENT. C IRCULATION. 2018 APR 10;137(15):1585-1594. DOI: 10.1161/CIRCULATIONAHA.117.030525. EPUB 2017 NOV 22. 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 EVALUATE THE EARLY OUTCOMES OF PATIENTS UNDERGOING AORTIC VALVE REPLACEMENT WITH OR WITHOUT AORTIC ROOT ENLARGEMENT. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 1990 TO AUGUST 2014. THE STUDY POPULATION INCLUDED 1,854 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 66 YEARS), 560 OF WHICH WERE IMPLANTED WITH A MEDTRONIC HANCOCK II BIOPROSTHETIC VALVE (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, 236 IN-HOSPITAL DEATHS OCCURRED. 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: BLEEDING REQUIRING INTERVENTION, ACUTE MYOCARDIAL INFARCTION (MI), LOW CARDIAC OUTPUT, ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, STERNAL WOUND INFECTION, SEPSIS, ATRIAL FIBRILLATION, STROKE, TRANSIENT ISCHEMIC ATTACK (TIA). 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
    720898 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T505

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R