BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1070925 · Received July 8, 2008

    Report

    Report Number
    2025587-2008-00058
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 6, 2008
    Report Date
    July 2, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: OTHER = NO INFO, CONCLUSION: OTHER = CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: TO DATE, THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS, AND DEVICE SPECIFIC INFO WAS NOT PROVIDED. RETURN OF THE DEVICE IS ANTICIPATED. CONCLUSION: NO DEFINITIVE CONCLUSIONS CAN BE DRAWN AT THIS TIME REGARDING THE PERFORMANCE OF THE DEVICE, AS THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS, AND PRODUCT SPECIFIC INFO WAS NOT PROVIDED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HOSP. SHOULD ADDITIONAL INFO BE OBTAINED, OR WHEN THE DEVICE IS RETURNED, A THOROUGH INVESTIGATION WILL BE COMPLETED, AND A SUPPLEMENTAL MDR WILL BE SUBMITTED. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS AORTIC BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED. THREE DAYS LATER, THE PT DEVELOPED SYMPTOMS OF ENDOCARDITIS AND WAS PROPHYLACTICALLY TREATED WITH ANTIBIOTICS, WHICH REPORTEDLY RESOLVED THE ISSUE. THE ANTIBIOTICS WERE SUBSEQUENTLY STOPPED. HOWEVER, AFTER STOPPING THE ANTIBIOTICS, THE SYMPTOMS RETURNED AND THE PT WAS SCHEDULED FOR REDO-AVR. IT WAS NOTED THAT THE PT DEVELOPED COMPLETE HEART BLOCK POST-OPERATIVE. THE CLINICIAN EXPRESSED CONCERN THAT THE ENDOCARDITIS WAS CAUSED BY A VALVE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC. 305 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R