BEUDAMED
    FDA Adverse Event Summary report: N

    MITROFLOW DLA

    MDR report key: 10090013 · Received May 26, 2020

    Report

    Report Number
    1718850-2020-01087
    Date Received
    May 26, 2020
    Date of Event
    March 25, 2020
    Report Date
    June 30, 2020
    Manufacturer
    LIVANOVA CANADA CORP
    Product Code
    LWR
    UDI-DI
    00896208000160
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED THE OPERATION REPORT IDENTIFYING THE FOLLOWING. PRE-OPERATIVE DIAGNOSIS WAS FOR CRITICAL AORTIC STENOSIS, SEVERELY REDUCED LEFT VENTRICULAR EJECTION FRACTION (15%), BIOPROSTHETIC VALVE DEGENERATION, INFLUENZA TYPE A INFECTION. THE SITE PERFORMED A 3RD TIME REDO STERNOTOMY WITH AN AORTIC ROOT RE-REPLACEMENT USING COMPOSITE MECHANICAL VALVED CONDUIT (25MM CARBOMEDICS TOP-HAT +28MM GELWEAVE VALSALVA). THE POST-OPERATIVE GRADIENT WAS 15MMHG VIA TEE AND THE PATIENT WAS TRANSPORTED BACK TO THORACIC INTENSIVE CARE IN A STABLE BUT CRITICAL CONDIITON. THE MANUFACTURING AND MATERIAL RECORDS FOR THE MITROFLOW BIOPROSTHETIC PERICARDIAL HEART VALVE, MODEL # DLA21, S/N # (B)(6), AS THEY PERTAIN TO THE REPORTED EVENT, WERE RETRIEVED AND REVIEWED BY QUALITY ENGINEERING AT LIVANOVA CANADA CORP. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A DLA21 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. SINCE THE VALVE WAS NOT AVAILABLE FOR RETURN OR ANALYSIS, NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. IT IS POSSIBLE THAT THE PATIENT'S RISK FACTORS CONTRIBUTED TO THE REPORTED STRUCTURAL VALVE DETERIORATION. HOWEVER, SINCE NO INVESTIGATION COULD BE PERFORMED, THIS CANNOT BE ULTIMATELY CONFIRMED. STRUCTURAL VALVE DETERIORATION IS LISTED AS A POSSIBLE ADVERSE EVENT IN THE DEVICE IFU. THE EVENT IS, THEREFORE, A KNOWN INHERENT RISK OF THE DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2016 A PATIENT RECEIVED A MITROFLOW DLA21 AORTIC HEART VALVE IMPLANT AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A CARBOMEDICS S5-025 MECHANICAL HEART VALVE PROSTHESIS. THE MANUFACTURER RECEIVED THE OPERATION REPORT IDENTIFYING THE FOLLOWING. PRE-OPERATIVE DIAGNOSIS WAS FOR CRITICAL AORTIC STENOSIS, SEVERELY REDUCED LEFT VENTRICULAR EJECTION FRACTION (15%), BIOPROSTHETIC VALVE DEGENERATION, INFLUENZA TYPE A INFECTION. THE SITE PERFORMED A 3RD TIME REDO STERNOTOMY WITH AN AORTIC ROOT RE-REPLACEMENT USING COMPOSITE MECHANICAL VALVED CONDUIT (25MM CARBOMEDICS TOP-HAT +28MM GELWEAVE VALSALVA). THE POST-OPERATIVE GRADIENT WAS 15MMHG VIA TEE AND THE PATIENT WAS TRANSPORTED BACK TO THORACIC INTENSIVE CARE IN A STABLE BUT CRITICAL CONDITION.

    Description of Event or Problem · 1

    ON (B)(6) 2016 A PATIENT RECEIVED A MITROFLOW DLA21 AORTIC HEART VALVE IMPLANT AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A CARBOMEDICS S5-025 MECHANICAL HEART VALVE PROSTHESIS. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553010 MITROFLOW DLA TISSUE HEART VALVE LWR LIVANOVA CANADA CORP DLA21 00896208000160

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR