BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 4496012 · Received February 9, 2015

    Report

    Report Number
    2025587-2015-00173
    Event Type
    Injury
    Date Received
    February 9, 2015
    Date of Event
    April 1, 2014
    Report Date
    February 24, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. ALSO, THE OCCURRENCE OF ENDOCARDITIS IN THIS EVENT IS GREATER THAN 12 MONTHS POST IMPLANT. BASED ON THE DESCRIPTIVE COMMENTS OUTLINED FROM THE JOURNAL LITERATURE, COMPLAINTS WHICH OCCURRED GREATER THAN 12 MONTHS POST IMPLANT ARE LARGELY CONSIDERED TO BE COMMUNITY ACQUIRED (REFER TO NOTE 1 BELOW). THEREFORE, THE ENDOCARDITIS IS HIGHLY UNLIKELY TO HAVE ORIGINATED FROM THE DEVICE AND/OR MANUFACTURING VALVE PROCESS. ENDOCARDITIS, REGURGITATION, AND CUSPAL TEAR RELATED RISKS ARE ADDRESSED IN THE CURRENT RISK MANAGEMENT FILE. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 47 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE PATIENT WAS ADMITTED FOR ENDOCARDITIS, WHICH WAS TREATED MEDICALLY. SEVERE AORTIC INSUFFICIENCY WAS TREATED MEDICALLY. FIFTY-FIVE (55) MONTHS POST-IMPLANT, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SEVERE HEART FAILURE SYMPTOMS. THE AORTIC VALVE BIOPROSTHESIS WAS EXPLANTED AND THE MITRAL VALVE WAS ALSO REPLACED. AT EXPLANT OF THE AORTIC VALVE, SIGNIFICANT DISEASE WAS NOTED ON THE LEAFLETS, INCLUDING A TEAR OF THE RIGHT LEAFLET OFF OF THE RIGHT NON-COMMISSURE. IN THE PHYSICIAN'S OPINION, THE TORN LEAFLET REPRESENTED THE MAJORITY OF THE MECHANISM OF THE AORTIC INSUFFICIENCY. UPON REMOVAL FROM CARDIOPULMONARY BYPASS (CPB), THE HEART REQUIRED ONE ROUND OF DEFIBRILLATION. AFTER A FEW MINUTES OF REST, THE HEART WAS FILLED FOR DE-AIRING, AND BRISK BLEEDING WAS NOTED BETWEEN THE AORTA AND THE SUPERIOR VENA CAVA. EXPLORATION REVEALED THAT THE BLEEDING WAS DUE TO A TEAR IN THE ROOF OF THE LEFT ATRIUM, WHICH WAS REPAIRED. THE PATIENT WAS THEN WEANED OFF OF CPB WITHOUT DIFFICULTY. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92043 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 305C227

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention