BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITROFLOW LXA

    MDR report key: 7389035 · Received April 2, 2018

    Report

    Report Number
    3004478276-2018-00162
    Event Type
    Death
    Date Received
    April 2, 2018
    Report Date
    April 2, 2018
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS NOTIFIED OF THIS SERIOUS ADVERSE EVENT BY THE FDA. THE FDA REFERENCE PROVIDED IS: (B)(4). THE MANUFACTURER HAS ALREADY REPORTED THIS EVENT DIRECTLY TO THE FDA IN RESPONSE TO REQUESTS ASSOCIATED WITH FDA REFERENCE: (B)(4). THE MANUFACTURER MADE THE FOLLOWING ATTEMPTS TO ACQUIRE FURTHER INFORMATION PERTAINING TO THE CASE: MAR. 19, 2018: CONTACTED (B)(6) HOSPITAL AND SPOKE TO (B)(6), BAN, RN, CNOR. SHE WAS REGISTERED AS THE REPORTING MEMBER FROM (B)(6) HOSPITAL ON ETQ. WAS INFORMED THAT ANOTHER MEMBER OF THE HOSPITAL, (B)(6), IS RESPONSIBLE FOR FDA REPORTING OF ALL CASES WITHIN (B)(6)'S DEPARTMENT. CALLED (B)(6) ON MAR. 19, 2018. NO ANSWER. LEFT A MESSAGE STATING THE CASE BASICS AND ASKING FOR HIM TO FOLLOW-UP. EMAILED (B)(6) TO FOLLOW-UP MAR. 20, 2018: RECEIVED FOLLOW-UP FROM (B)(6) MAR. 21, 2018: NO FURTHER INFORMATION AVAILABLE. AT THIS TIME, THE MANUFACTURER IS NOT ABLE TO OBTAIN ANY FURTHER CASE INFORMATION. THIS CASE IS REPORTING THE SECOND INCIDENT ASSOCIATED WITH CASE (B)(4).

    Description of Event or Problem · 1

    ON MARCH 2, 2018 HV CQ RECEIVED FROM FDA THE FOLLOWING INFORMATION: USER FACILITY REPORT NUMBER: (B)(4). DATE RECEIVED: 02-FEB-2018. ADVERSE EVENT OR PRODUCT PROBLEM: ADVERSE EVENT: Y. PRODUCT PROBLEM: OUTCOMES ATTRIBUTED TO EVENT: DEATH. EVENT DATE: (B)(6) 2017. DATE OF REPORT: 23-JAN-2018. EVENT DESCRIPTION: PT WAS IN SURGERY FOR "HIGH RISK" RE-DO AORTIC VALVE REPLACEMENT AFTER RECEIVING MITROFLO 23MM VALVE IN 2012, PER DR (B)(6), PT DID NOT SUSTAIN BLOOD PRESSURES IN ATTEMPT TO COME OFF CARDIO-PULMONARY BYPASS IN SEVERAL ATTEMPTS. PT DIED IN OPERATING ROOM AFTER INCISION WAS CLOSED. PT'S FAMILY DID NOT WISH TO ATTEMPT MECHANICAL SUPPORT. ON (B)(6) 2017 WE HAD A PT WHO HAD A MITROFLOW VALVE DYSFUNCTION WHICH LEAD TO ANOTHER SURGERY THAT WAS COMPLETED BY DR.(B)(6). RL SOLUTIONS WAS FILED AND THE DEVICE WAS SEQUESTERED FROM PATHOLOGY AND GIVEN TO SAFETY AND SECURITY. (B)(6) BROUGHT TO MY ATTENTION THAT ON (B)(6) 2017 WE HAD A PT WHO HAD TO HAVE A MITROFLOW VALVE REMOVED (PLACED IN 2012). ACCORDING TO DR (B)(6)'S NOTE, THE MITROFLOW AORTIC VALVE LEAFLETS HAD SEVERE CALCIFICATION INVOLVING ALL 3 CUSPS AND THE LEFT AND RIGHT CUSPS WERE FUSED. THIS PT ENDED UP DYING IN THE OPERATING ROOM. AN RL SOLUTIONS HAS BEEN COMPLETED AND I SEQUESTERED THE VALVE FROM PATHOLOGY AND GAVE IT TO SAFETY AND SECURITY AS WELL. THIS IS THE 2ND PT IN 90 DAYS THAT WE HAVE OPERATED ON TO REMOVE THIS KIND OF VALVE. I ASKED FOR ASSISTANCE IN WHA. THIS REPORT IS REFERRING TO THE SECOND INCIDENT. THERE IS AN ASSOCIATED REPORT: (B)(4) THAT REFERS TO THE FIRST INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232797 MITROFLOW LXA TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death