BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 3031036 · Received April 2, 2013

    Report

    Report Number
    2025587-2013-00052
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE SERIAL NUMBER WAS NOT PROVIDED. FROM THE INFORMATION RECEIVED THE VALVE WAS EXPLANTED AFTER APPROXIMATELY FOURS YEARS DUE TO STENOSIS AND CALCIFICATION AFTER BEING IMPLANTED FOR FOUR YEARS. THE VALVE WAS NOT RETURNED. WITHOUT THE RETURN OF THE VALVE FOR ANALYSIS, A ROOT CAUSE COULD NOT BE DETERMINED, HOWEVER, CALCIFICATION OF A TISSUE VALVE IS CONSIDERED PATIENT-RELATED AND NOT A MALFUNCTION OF THE VALVE. (B)(6). (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED FOUR YEARS, WAS EXPLANTED. UPON VISUAL INSPECTION, THERE WAS CALCIFICATION ON THE VALVE AND THE VALVE APPEARED THICKENED. THE DEVICE WILL NOT BE RETURNED AND THE SERIAL NUMBER UNKNOWN. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134739 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA T510

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R