BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    MDR report key: 3942613 · Received July 17, 2014

    Report

    Report Number
    2015691-2014-01618
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    December 17, 2013
    Report Date
    June 20, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: IT WAS REPORTED THAT THIS RING WAS EXPLANTED DUE TO ENDOCARDITIS. PROSTHETIC ENDOCARDITIS, WITH OR WITHOUT VEGETATION, OF VALVES AND ANNULOPLASTY RINGS IS A SERIOUS COMPLICATION OF CARDIAC VALVE REPLACEMENT AND VALVE REPAIR SURGERIES DESPITE IMPROVEMENTS IN PROSTHESES TYPES, SURGICAL TECHNIQUES, AND INFECTION CONTROL MEASURES. THIS INFECTION IS GENERALLY CATEGORIZED INTO EARLY (USUALLY LESS THAN 60 DAYS POSTOPERATIVE) AND LATE (GREATER THAN 60 DAYS POST-IMPLANTATION). PROSTHETIC ENDOCARDITIS OCCURRING WITHIN 60 DAYS OF VALVE OR RING IMPLANTATION GENERALLY REFLECTS CONTAMINATION ARISING IN THE PERIOPERATIVE PERIOD. THERE ARE MANY OPPORTUNITIES FOR ORGANISMS TO SEED A PROSTHESIS PERIOPERATIVELY, MOST OF WHICH PROBABLY OCCURS INTRAOPERATIVELY. BESIDES THE PATIENT'S OWN SKIN AND ACCESS LINES, SEVERAL OTHER IMPORTANT MODES OF CONTAMINATION HAVE BEEN RECOGNIZED INCLUDING AIR IN THE OPERATING ROOM, THE CORONARY SUCTION DEVICES USED DURING SURGERY AND THE HEART-LUNG BYPASS MACHINE, FAULTY TECHNIQUE DURING CARDIAC OUTPUT MEASUREMENTS, AND THE PROSTHESIS ITSELF. IN EARLY CASES OF PROSTHETIC ENDOCARDITIS, SUBSEQUENT INFECTIONS ARE ALMOST UNIVERSALLY RELATED TO CONTAMINATION AT THE TIME OF SURGERY. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THERE IS NO INFORMATION SUGGESTING THAT THE EDWARDS DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVEDUE TO THE ENDOCARDITIS OF THE NATIVE MITRAL VALVE, HOLES WERE NOTED IN THE NATIVE LEAFLETS. THESE HOLES WERE REPAIRED WITH AUTOLOGOUS PERICARDIAL PATCH. DESPITE THE EFFECTIVE MITRAL VALVE REPAIR INITIALLY OBTAINED DURING THE MITRAL REPAIR SURGERY, THE PATIENT¿S LEAFLET AND THE AUTOLOGOUS PATCH DISRUPTED PROMPTING THE RE-DO MITRAL VALVE SURGERY TO REPLACE THE MITRAL VALVE. THEREFORE, THE ENDOCARDITIS WAS NOT RELATED TO THE EDWARDS DEVICE AS ORIGINALLY REPORTED

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, EDWARDS RECEIVED INFORMATION THAT A PROSTHETIC MITRAL RING, IMPLANTED APPROXIMATELY ONE (1) MONTH AND TWO (2) DAYS, WAS EXPLANTED DUE TO ENDOCARDITIS. THE PATIENT'S MITRAL VALVE WAS REPLACED WITH AN EDWARDS BIOPROSTHETIC VALVE. NO OTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION HAS BEEN OBTAINED INDICATING THE PATIENT HAD NATIVE VALVE ENDOCARDITIS THAT PRECEDED THE EXPLANT OF THIS MITRAL ANNULOPLASTY RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418130 CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 5200 13E147

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R