BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK

    MDR report key: 9296819 · Received November 8, 2019

    Report

    Report Number
    2025587-2019-03421
    Event Type
    Injury
    Date Received
    November 8, 2019
    Date of Event
    November 16, 1981
    Report Date
    November 8, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P790007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SUTTON TM ET AL. LONG-TERM HEMODYNAMIC ASSESSMENT OF THE HANCOCK PORCINE-VALVED CONDUIT. CIRCULATION 1981;64 (SUPPL 4):31. DOI: NOT AVAILABLE. PRESENTED AT THE 54TH SCIENTIFIC SESSIONS OF THE AMERICAN HEART ASSOCIATION NOVEMBER 16-19, 1981 DALLAS CONVENTION CENTER DALLAS, TEXAS. 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 THE 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. [(B)(4)].

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE LONG-TERM HEMODYNAMIC ASSESSMENT IN PATIENTS WHO WERE TREATED WITH THE HANCOCK PORCINE-VALVED CONDUIT. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN NOVEMBER 1972 AND DECEMBER 1977. THE STUDY POPULATION INCLUDED 411 PATIENTS (MEAN AGE 11 YEARS), ALL WERE IMPLANTED WITH MEDTRONIC HANCOCK VALVED CONDUITS (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, 81 PERI-OPERATIVE DEATHS OCCURRED. NO OTHER DETAILS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THESE 81 DEATHS. AN ADDITIONAL 46 DEATHS OCCURRED AT UNSPECIFIED DURATIONS FOLLOWING DISCHARGE FROM THE HOSPITAL. IT WAS REPORTED THAT AUTOPSIES WERE PERFORMED ON 29 OF THESE PATIENTS AND THE CONDUIT WAS NOTED TO BE NORMAL IN 10, OBSTRUCTED IN 14, AND OF UNKNOWN STATUS IN 5. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS ASSOCIATED WITH 14 OF THESE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: REOPERATION FOR CONDUIT OBSTRUCTION. THE CAUSES OF OBSTRUCTION WERE STATED TO BE FIBROUS INTIMAL PEEL, CALCIFICATION, COMBINATION OF BOTH, AND UNSPECIFIED OTHER CAUSE(S). ALSO OBSERVED: ELEVATED MEAN GRADIENT ACROSS THE CONDUIT (GREATER THAN OR EQUAL TO 50 MM HG). BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS DIRECTLY 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
    1090282 HANCOCK HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION HC150-12

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention