BEUDAMED
    FDA Adverse Event Death Summary report: N

    HANCOCK II MITRAL 25MM

    MDR report key: 2851598 · Received November 29, 2012

    Report

    Report Number
    2025587-2012-00184
    Event Type
    Death
    Date Received
    November 29, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY AFTER THE IMPLANT OF THIS BIOPROSTHETIC MITRAL VALVE, WHILE COMING OFF BYPASS, TRANS ESOPHAGEAL ECHOCARDIOGRAM (TEE) NOTED THAT ONE OF THE LEAFLETS WAS NOT MOVING FREELY; GRADIENT ACROSS THE MITRAL VALVE WAS NOT HIGH BUT IT WAS SUSPECTED THAT THERE WAS LITTLE FLOW ACCELERATION ACROSS THE VALVE. THE PATIENT WAS PUT BACK ON BYPASS AND CROSS CLAMPED TO LOOK FOR REMNANTS OF THE NATIVE MITRAL SUB VALVULAR APPARATUS. NO STRUCTURE WAS FOUND TO BE INTERFERING WITH THE BIOPROSTHETIC VALVE AND THE BIOPROSTHETIC VALVE WAS MOVING FREELY. THE VALVE REMAINED IMPLANTED AND THE PATIENT WAS TAKEN OFF BYPASS. IT WAS NOTED THAT CROSS CLAMP TIME WAS LONG. ONE DAY POST OP, TEE REVEALED A GRADIENT OF >6 MMHG ACROSS THE MITRAL VALVE. REOPERATION WAS CONSIDERED BUT NOT ATTEMPTED DUE TO THE PATIENT'S UNDERLYING MEDICAL CONDITION. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR RENAL FAILURE (ON FOR DIALYSIS FOR 18 MONTHS PRIOR TO SURGERY) AND CARDIAC FAILURE. THE PATIENT REMAINED IN ICU FOR THE NEXT FOUR MONTHS AND SUBSEQUENTLY PASSED AWAY. CAUSE OF DEATH WAS UNSPECIFIED. IT WAS ALSO NOTED THAT THE INITIAL PROCEDURE WAS AN EMERGENT DOUBLE VALVE REPLACEMENT SURGERY OF A VERY SICK PATIENT WITH INFECTIVE ENDOCARDITIS ON BOTH AORTIC AND MITRAL VALVES. IT WAS REPORTED THAT THIS WAS THE PHYSICIAN'S FIRST EXPERIENCE IMPLANTING A VALVE OF THIS MODEL IN THE MITRAL POSITION. THE PHYSICIAN STATED THAT THIS SCENARIO COULD HAVE BEEN RELATED TO A TECHNICAL IMPLANT ISSUE BUT A PRODUCT MALFUNCTION COULD NOT BE EXCLUDED. THERE WERE NO ALLEGATIONS AGAINST THE AORTIC VALVE. THE MITRAL VALVE WAS REQUESTED TO BE RETURNED FOR ANALYSIS. THIRD PARTY ECHO REVIEW HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANCOCK II MITRAL 25MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA T510

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Death