BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITROFLOW DLA

    MDR report key: 7101059 · Received December 8, 2017

    Report

    Report Number
    3004478276-2017-00213
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    November 15, 2016
    Report Date
    March 9, 2018
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000177
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER COMMUNICATION ON FEB. 14, 2018 NO MORE INFORMATION IS AVAILABLE AND THE DEVICE WILL NOT BE RECEIVED. IF FURTHER INFORMATION IS RECEIVED THE INVESTIGATION WILL BE REASSESSED. DEVICE NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED TO THE MANUFACTURER THROUGH THE (B)(6) REGISTRY. BASED ON INTERNAL CLINICAL ASSESSMENT THE EVENT WAS DETERMINED TO BE UNKNOWN IF DEVICE RELATED. AS REPORTED IN THE MITROFLOW DL INSTRUCTIONS FOR USE: "ADVERSE EVENTS POTENTIALLY ASSOCIATED WITH THE USE OF BIOPROSTHETIC HEART VALVES (IN ALPHABETICAL ORDER) INCLUDE (BUT MAY NOT BE LIMITED TO): ANGINA, CARDIAC ARRHYTHMIAS... THROMBOEMBOLISM, VALVE THROMBOSIS. IT IS POSSIBLE THAT THESE COMPLICATIONS COULD LEAD TO: REOPERATION, EXPLANT, PERMANENT DISABILITY, DEATH." AS SUCH, THIS IS A KNOWN INHERENT RISK OF AORTIC VALVE REPLACEMENT. FURTHERMORE, AS REPORTED BY RUEL ET AL, "STROKE IS A DEVASTATING COMPLICATION THAT MAY OCCUR EARLY OR LATE AFTER OPERATION IN PATIENTS WITH PROSTHETIC HEART VALVES AND RESULT FROM EMBOLISM, INTRACRANIAL HEMORRHAGE, OR BOTH. ALTHOUGH INTRACRANIAL HEMORRHAGE IS A RELATIVELY RARE EVENT EXCEPT IN ELDERLY ANTICOAGULATED PATIENTS, AN EMBOLIC STROKE MAY OCCUR IN VIRTUALLY ANY PATIENT AND WITH ANY TYPE OF VALVE PROSTHESIS. RISK FACTORS FOR STROKE IN THE GENERAL POPULATION INCLUDE ADVANCED AGE, ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE, CONGESTIVE HEART FAILURE, MITRAL ANNULAR CALCIFICATION, HYPERTENSION, DIABETES, AND SMOKING. IN PATIENTS WITH PROSTHETIC HEART VALVES, THESE AND OTHER PATIENT-RELATED CHARACTERISTICS COULD INTERPLAY WITH THE DESIGN OF THE PROSTHESIS, THE SITE OF IMPLANTATION, AND THE ADEQUATENESS OF ANTICOAGULATION." [1] [1] RUEL, MARC, ET AL. "LATE INCIDENCE AND DETERMINANTS OF STROKE AFTER AORTIC AND MITRAL VALVE REPLACEMENT." THE ANNALS OF THORACIC SURGERY 78.1 (2004): 77-83.

    Description of Event or Problem · 1

    A MITROFLOW DLA23 WAS IMPLANTED ON (B)(6) 2014 VIA MEDIAN-STERNOTOMY. ON (B)(6) 2016, THE PATIENT EXHIBITED A STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880506 MITROFLOW DLA TISSUE HEART VALVES LWR LIVANOVA CANADA CORP. DLA23 00896208000177

    Patients

    Seq Age Sex Outcome Treatment
    1 Other