BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 11155635 · Received January 12, 2021

    Report

    Report Number
    2025587-2021-00128
    Event Type
    Injury
    Date Received
    January 12, 2021
    Date of Event
    June 8, 2020
    Report Date
    January 12, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: PETERSEN J ET AL. LONG-TERM OUTCOME AND QUALITY OF LIFE AFTER BIOLOGICAL AORTIC VALVE REPLACEMENT IN NONELDERLY ADULTS. ANN THORAC SURG. 2021 JAN;111(1):142-149. DOI: 10.1016/J.ATHORACSUR.2020.04.097. EPUB 2020 JUN 8. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. 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 FROM A LITERATURE ARTICLE REGARDING THE LONG-TERM OUTCOMES AND QUALITY OF LIFE IN PATIENTS YOUNGER THAN 60 YEARS WHO UNDERWENT SURGICAL AORTIC VALVE REPLACEMENT. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2005 AND DECEMBER 2015. THE STUDY POPULATION INCLUDED 354 PATIENTS AND WAS PREDOMINANTLY MALE WITH A MEAN AGE OF 52 YEARS. APPROXIMATELY 83 PATIENTS WERE IMPLANTED WITH MEDTRONIC HANCOCK II BIOPROSTHETIC VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 53 DEATHS OCCURRED WITHIN 12 YEARS AFTER VALVE IMPLANT. THE DEATHS WERE ATTRIBUTED TO CARDIAC CAUSES (17), NON-CARDIAC CAUSES (16), OR UNCLEAR CAUSES (20). MULTIPLE MANUFACTURERS BIOPROSTHETIC VALVES WERE IMPLANTED IN THE STUDY POPULATION. NONE OF THE DEATHS WERE DIRECTLY ASSOCIATED WITH MEDTRONIC PRODUCT. AMONG ALL PATIENTS, POST-OPERATIVE ADVERSE EVENTS INCLUDED: REDO SURGERY DUE TO BLEEDING, PERMANENT PACEMAKER IMPLANTATION, MYOCARDIAL INFARCTION, CEREBROVASCULAR EVENTS/STROKE, MODERATE TO SEVERE AORTIC REGURGITATION, PARAVALVULAR LEAKAGE, ELEVATED MEAN GRADIENTS (GREATER THAN OR EQUAL TO 20 MMHG), AND AORTIC VALVE REINTERVENTION (REDO SURGERY OR TRANSCATHETER VALVE-IN-VALVE REPLACEMENT) DUE TO STRUCTURAL VALVE DEGENERATION OR ENDOCARDITIS. 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
    51724 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION T505

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R