BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 2960104 · Received February 13, 2013

    Report

    Report Number
    2025587-2013-00028
    Event Type
    Injury
    Date Received
    February 13, 2013
    Report Date
    January 14, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD, INCLUDING THE STERILIZATION LOT RECORD, WAS REVIEWED AND FOUND TO BE ACCEPTABLE. THIS PATIENT WAS DIAGNOSED WITH EARLY ENDOCARDITIS AND VALVE INSUFFICIENCY. THE LAST REPORT INDICATES THAT THE VALVE REMAINS IMPLANTED, THE PATIENT IS ASYMPTOMATIC AND IS BEING TREATED WITH ANTIBIOTICS. A TRUE ROOT CAUSE TO THE REPORTED CLINICAL OBSERVATIONS IS NOT DETERMINED. ENDOCARDITIS CASES THAT OCCUR WITHIN TWO MONTHS AFTER THE PROCEDURE ARE CALLED EARLY PROSTHETIC-VALVE ENDOCARDITIS, AND ARE USUALLY ACQUIRED WHILE THE PATIENT IS IN THE HOSPITAL (NOSOCOMIAL INFECTION). THESE CASES MAY ALSO BE DUE TO INTRODUCTION OF THE MICROORGANISM DURING THE IMPLANT PROCEDURE (1). IN THIS CASE, SOURCE OF THE ENDOCARDITIS IS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED. (1) MYLONAKIS, E., AND CALDERWOOD, S.B. INFECTIVE ENDOCARDITIS IN ADULTS. NEW ENGLAND JOURNAL OF MEDICINE. 345 (18). 1318-1330. NOV.1, 2001. (B)(6). (B)(4).

    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 APPROXIMATELY THREE WEEKS FOLLOWING THE IMPLANT OF THIS BIOPROSTHETIC VALVE, ECHOCARDIOGRAPHY REVEALED EARLY ENDOCARDITIS AND VALVE INSUFFICIENCY. THERE WAS NO VEGETATION, BUT THE VALVES WERE THICKENED AND IMMOBILE. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND RESPONDED WELL TO THE TREATMENT. BLOOD CULTURES WERE TAKEN BUT THE SOURCE OF THE ENDOCARDITIS WAS UNKNOWN. THERE WAS NO ALLEGATION THAT THE VALVE CAUSED OR CONTRIBUTED TO THE ENDOCARDITIS. THE VALVE REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63775 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA FR995-25

    Patients

    Seq Age Sex Outcome Treatment
    1 Other