BEUDAMED
    FDA Adverse Event Death Summary report: N

    HANCOCK 2 VALVE

    MDR report key: 4163149 · Received October 6, 2014

    Report

    Report Number
    MW5038542
    Event Type
    Death
    Date Received
    October 6, 2014
    Date of Event
    June 2, 2014
    Report Date
    October 6, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    DYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT WAS A (B)(6) FEMALE WHO UNDERWENT TISSUE AVR/TUBE GRAFT REPLACEMENT OF THE AORTA ON (B)(6) 2014. THREE PRODUCTS WERE USED ON THE PT INCLUDING BARD VASCULAR FELT LOT # HUYA0437 EXP: 01/01/2019. DR (B)(6) WAS THE SURGEON. BY ALL INDICATIONS THE SURGERY WAS SUCCESSFUL. ON (B)(6) 2014, WHILE VISITING RELATIVES IN (B)(6), THE PT BEGAN RUNNING A FEVER AND HAD WORD FINDING DIFFICULTIES. UPON ADMISSION INTO THE ER, A HEAD CT REVEALED AN ACUTE SUBARACHNOID HEMORRHAGE AND THE CTA OF THE THORAX DISCOVERED A MASS IN THE AREA OF THE REPLACED VALVE. ON (B)(6) 2014, THE SURGEON AT (B)(6) MEDICAL CENTER ((B)(6)) REMOVED THE INFECTED ASCENDING AORTIC GRAFT AND VALVE AND REPLACED. THE EXPLANTED PRODUCTS WERE FOUND TO HAVE A FUNGAL INFECTION IDENTIFIED AS RHIZOPUS. (B)(6) INFECTION PREVENTION AND CONTROL NOTIFIED (B)(6) AT THAT TIME OF THE ISSUE. ON (B)(6) 2014, THE PT WAS SITTING UP IN A CHAIR AND WANTED TO GET FRESH AIR. SHE HAD INFECTION AT THE TIME BUT WAS PROGRESSING WELL. ON (B)(6) 2014, THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625015 HANCOCK 2 VALVE HANCOCK VALVE DYE MEDTRONIC
    625016 VASCUTEK GEL WEAVE GRAFT GEL WEAVE GRAFT DSY TERUMO 3193275771
    625056 BARD PTFE FELT PTFE FELT DXZ BARD HUYA0437

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death