BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK

    MDR report key: 9504707 · Received December 20, 2019

    Report

    Report Number
    2025587-2019-03855
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    January 30, 2019
    Report Date
    December 20, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P790007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: JEWGENOW P ET AL. SUBCLINICAL THROMBUS FORMATION IN BIOPROSTHETIC PULMONARY VALVE CONDUITS. INT J CARDIOL. 2019 APR 15;281 :113-118. DOI: 10.1016/J.IJCARD.2019.01.095. EPUB 2019 JAN 30. 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 A HISTOPATHOLOGIC ANALYSIS OF EXPLANTED BIOPROSTHETIC PULMONARY VALVE CONDUITS FOR SUBCLINICAL THROMBUS FORMATION. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS. THE STUDY INCLUDED 47 EXPLANTED PULMONARY CONDUITS FROM PATIENTS WITH A HISTORY OF CONGENITAL HEART DISEASE AND CONCOMITANT PULMONARY VALVE STENOSIS AND/OR INSUFFICIENCY. THE MEAN AGE OF THE PATIENT POPULATION WAS 5.6 YEARS. OF THE EXPLANTED CONDUITS, 39 WERE MEDTRONIC PRODUCTS: HANCOCK (23), CONTEGRA (7), MELODY (7), AND FREESTYLE (2). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: CONDUIT EXPLANTATION DUE TO PULMONARY STENOSIS AND/OR PULMONARY INSUFFICIENCY (OBSERVED IN HANCOCK, CONTEGRA AND MELODY); AND SUBCLINICAL THROMBUS FORMATION AT THE BASE OF THE VALVE SINUS. IT WAS REPORTED THAT THE DURATION FROM CONDUIT IMPLANTATION TO CONDUIT EXPLANTATION WAS A MEAN 63 MONTHS (6 TO 342 MONTHS). 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
    1295004 HANCOCK HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION HC150-12

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention