BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 4674514 · Received April 9, 2015

    Report

    Report Number
    2025587-2015-00413
    Event Type
    Injury
    Date Received
    April 9, 2015
    Date of Event
    February 18, 2015
    Report Date
    April 29, 2015
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THIS VALVE WAS EXPLANTED AND REPLACED DUE TO, CONGESTIVE HEART FAILURE (CHF) AND ENDOCARDITIS. UPON EXPLANT, CALCIFICATIONS, VEGETATIONS, AND SOME TISSUE GROWTHS WERE PRESENT. NO CULTURES WERE INDICATED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE REASON FOR EXPLANT. AT THE TIME OF THIS REPORT MEDTRONIC HAS NOT RECEIVED THIS INFORMATION. (B)(4).

    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 STERILIZATION PROCESS USED BY MEDTRONIC HAS AN ANTI-MICROBIAL KILL ON MICROORGANISMS, AND HAS DEMONSTRATED THE ABILITY TO INACTIVATE THE BIOLOGICAL INDICATOR WHICH IS REPRESENTATIVE BIO BURDEN FOR THE MICROBIAL FLORA FOUND IN OUR MANUFACTURING CONTROLLED ENVIRONMENT. IN ADDITION, THE OCCURRENCE OF ENDOCARDITIS WAS GREATER THAN 12 MONTHS POST IMPLANT. BASED ON THE DESCRIPTIVE COMMENTS OUTLINED FROM THE JOURNAL LITERATURE, ENDOCARDITIS OCCURRING GREATER THAN 12 MONTHS POST IMPLANT IS LARGELY CONSIDERED TO BE COMMUNITY ACQUIRED (REFER TO NOTE 1 BELOW). THEREFORE, IT IS UNLIKELY THAT THE ENDOCARDITIS ORIGINALLY CAME FROM THE DEVICE AND/OR MANUFACTURING VALVE PROCESS. WITHOUT THE RETURN OF THE VALVE, A ROOT CAUSE FOR THE CLINICAL OBSERVATION WAS UNABLE TO BE DETERMINED. MEDTRONIC WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR SIMILAR EVENTS SHOULD THEY OCCUR. NOTE 1 - MYLONAKIS, E., AND CALDERWOOD, S.B. INFECTIVE ENDOCARDITIS IN ADULTS. NEW ENGLAND JOURNAL OF MEDICINE. 345 (18). 1318-1330. NOV. 1, 2001.

    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 ONE YEAR, FOUR MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236216 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA 305C221

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention