BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY RING

    MDR report key: 2083919 · Received May 11, 2011

    Report

    Report Number
    2015691-2011-15504
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    September 23, 2010
    Report Date
    April 11, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS DISCARDED BY THE HOSPITAL. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. ENDOCARDITIS OCCURRING EARLY POST-OPERATIVELY, WITHIN 60 DAYS, IS USUALLY DUE TO PERIOPERATIVE BACTERIAL CONTAMINATION OF THE VALVE. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. IN THIS CASE, THE INFECTION WAS KNOWN AS PSEUDOMONAS, SOURCE OF THE INFECTION IS UNKNOWN. WITHOUT ADEQUATE INFORMATION FROM THE HEALTH CARE PROVIDER, WE CANNOT CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR EXPLANT OF THIS DEVICE.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR STERILIZED 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, AN ANNULOPLASTY RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF 21 DAYS (0.70 MONTHS) AND WAS REPLACED BY THE SAME SIZE, SAME MODEL RING DUE TO ENDOCARDITIS - PSEUDOMONAS, SOURCE WAS NOT PROVIDED. IN THE SURGEON'S RESPONSE, IT WAS NOTED THAT THE EXPLANT OF THIS DEVICE WAS NOT DUE TO A DEVICE MALFUNCTION. INFORMATION WAS PROVIDED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT AN MVR WITH A SJM MECHANICAL VALVE 27MM AND A TRICUSPID ANNULOPLASTY RING WITH AN MC3 30MM. THE PATIENT DEVELOPED SEPTIC DETERIORATION FOLLOWING ENDOCARDITIS (PSEUDOMONAS) AND WAS RE-OPERATED ON (B)(6): REDO MVR WITH A SJM MECHANICAL VALVE 33MM AND A TRICUSPID ANNULOPLASTY RING WITH A MC3 30MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 R-10G1788

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R