BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 6560189 · Received May 11, 2017

    Report

    Report Number
    2025587-2017-00783
    Event Type
    Injury
    Date Received
    May 11, 2017
    Date of Event
    April 8, 2017
    Report Date
    June 21, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    UDI-DI
    00643169001619
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE EXPLANTED DEVICE WAS NOT RETURNED FOR ANALYSIS. WITHOUT THE RETURN OF THE VALVE FOR ANALYSIS, A DEFINITIVE ROOT CAUSE OF THE PROLAPSED LEAFLET CANNOT BE DETERMINED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE SUSPECTED ENDOCARDITIS HAVE BEEN UNSUCCESSFUL. THIS EVENT THE OCCURRENCE OF POTENTIAL ENDOCARDITIS WAS GREATER THAN 12 MONTHS POST IMPLANT (GREATER THAN 4 YEARS). BASED ON THE DESCRIPTIVE COMMENTS OUTLINED FROM THE JOURNAL LITERATURE, COMPLAINTS WHICH OCCURRED GREATER THAN 12 MONTHS POST IMPLANT WERE LARGELY CONSIDERED TO BE COMMUNITY ACQUIRED (REFER TO NOTE 1). THEREFORE, IT WAS UNLIKELY THAT THE ENDOCARDITIS ORIGINALLY CAME FROM THE DEVICE AND/OR MANUFACTURING VALVE PROCESS. NOTE 1 - MYLONAKIS, E., AND CALDERWOOD, S.B. INFECTIVE ENDOCARDITIS IN ADULTS. NEW ENGLAND JOURNAL OF MEDICINE. 345 (18). 1318-1330. NOV.1, 2001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED STATES THE MITRAL BIOPROSTHETIC VALVE EXHIBITED SEVERE MITRAL REGURGITATION DUE TO A PROLAPSED LEAFLET, WITH SUSPECTED BUT NOT CONFIRMED ENDOCARDITIS. THE DEVICE WAS EXPLANTED AND SENT TO HOSPITAL PATHOLOGY. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOUR YEARS, SIX MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THIS DEVICE WAS REPLACED WITH A BIOPROSTHETIC MITRAL VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342456 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 310C 00643169001619

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention