BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 3934831 · Received July 15, 2014

    Report

    Report Number
    2025587-2014-00477
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    August 7, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED AS OF THE TIME OF THIS REPORT. WITHOUT THE RETURN OF THE VALVE FOR ANALYSIS, A ROOT CAUSE OF THE THROMBUS CANNOT BE DETERMINED. HOWEVER, BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS VALVE, THERE WERE NO NON-CONFORMANCES IDENTIFIED IN MANUFACTURING AND STERILIZATION (RAW MATERIALS, MANUFACTURING TIME PERIOD, PACKAGING AND LABELING, OR THE STERILIZATION PROCESS) THAT COULD BE RELATED TO THIS EVENT. THIS DEVICE WAS MANUFACTURED PER APPROVED AND RELEASED MANUFACTURING PROCESSES AND MET ALL APPLICABLE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION. ADDITIONAL INVESTIGATION WILL BE PERFORMED IF THE DEVICE IS RETURNED FOR ANALYSIS OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE EVENT DATE INITIALLY REPORTED WAS THE DATE OF THE INITIAL IMPLANT; THE CORRECTED EVENT DATE LISTED HERE IS THE DATE OF THE REPORTABLE SURGICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    DESCRIPTION ADDITION: THE PATIENT HAD A HISTORY OF AN ISCHEMIC NATIVE MITRAL VALVE, WHICH CONTRIBUTED TO THE NATIVE MITRAL VALVE REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT ELEVEN DAYS POST-IMPLANT OF THIS MITRAL VALVE BIOPROSTHESIS (B182683), A REPEAT TRANSTHORACIC EC HOCARDIOGRAM (TTE) AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) INDICATED THAT THE VALVE HAD ACUTELY THROMBOSED. THE PATIENT HAD SEVERAL CARDIAC ARRESTS, AND THE VALVE WAS EXPLANTED AND REPLACED WITH A NEW BIOPROSTHETIC MITRAL VALVE (B193749). THE PATIENT HAD NO KNOWN INFLAMMATORY OR HYPERCOAGULABLE DISORDERS. TWELVE DAYS FOLLOWING THE REVISION PROCEDURE, THE PATIENT EXPIRED AFTER RECEIVING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. THE CAUSE OF DEATH WAS REPORTED AS CARDIAC; HOWEVER NO AUTOPSY WILL BE PERFORMED. THE EXPLANTED VALVE WILL BE RETURNED FOR ANALYSIS AFTER THE FACILITIES PATHOLOGY DEPARTMENT HAS COMPLETED ITS EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413904 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 310C27

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention