BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANCOCK 11 PORCINE HEART VALVE, SIZE TI

    MDR report key: 3840199 · Received May 22, 2014

    Report

    Report Number
    MW5036325
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    March 20, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    DTI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, A (B)(6) YEAR OLD FEMALE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR MITRAL AND TRICUSPID VALVE SURGERY. DURING SURGERY, UPON THE SURGEON SEATING THE 33-HANCOCK II MITRAL PROSTHESIS, THE SURGEON COULD SEE DISRUPTION OF LEAFLETS FROM THE SEWN RING. BECAUSE OF THIS, THE PROSTHESIS WAS NOT SEATED AND IT WAS REMOVED. THE PROSTHESIS WAS REPLACED WITH A 231 BOVINE PERICARDIAL VALVE AND THIS PROSTHESIS WAS SUCCESSFULLY SEATED WITH GOOD APPOSITION ON THE ANNULUS. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE CARDIAC SURGERY ICU FOR ROUTINE POSTOPERATIVE CARE. SITE WAS SUBSEQUENTLY DISCHARGED ON (B)(6) 2014. THERE WAS NO ADVERSE EVENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304235 HANCOCK 11 PORCINE HEART VALVE, SIZE TI HANCOCK 11 PORCINE HEART VALVE, SIZE TI DTI MEDTRONIC 33M12J5378

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR