BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 10041622 · Received May 10, 2020

    Report

    Report Number
    2025587-2020-01602
    Event Type
    Injury
    Date Received
    May 10, 2020
    Date of Event
    October 22, 2019
    Report Date
    May 10, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HUDZIAK D ET AL. INFECTIOUS ENDOCARDITIS AFTER VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE IMPLANTATION: REOPERATIVE TREATMENT OF INFECTIOUS ENDOCARDITIS. KARDIOLOGIA POLSKA. 2020; 78(1):84-85. DOI: 10.33963/KP.15029. 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 (B)(6)-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF ATRIAL FIBRILLATION, CHRONIC RENAL INSUFFICIENCY, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ANEMIA, AND GASTROINTESTINAL TRACT BLEEDING WHO UNDERWENT IMPLANT OF A 23MM MEDTRONIC HANCOCK II BIOPROSTHETIC VALVE WITH A CONCOMITANT LEFT INTERNAL MAMMARY ARTERY GRAFT. NO SERIAL NUMBERS WERE PROVIDED. APPROXIMATELY 3 YEARS POST IMPLANT, A MEDTRONIC EVOLUT R TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE BECAUSE OF ELEVATED GRADIENTS (108MMHG MAXIMUM GRADIENT, 58MM MEAN GRADIENT). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505289 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION T505

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention