BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY RING

    MDR report key: 2001428 · Received February 25, 2011

    Report

    Report Number
    2015691-2011-14885
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    June 30, 2010
    Report Date
    January 26, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN LEARNED THOUGH FOLLOW-UP WITH THE HEALTHCARE PROVIDER THAT THE EXPLANT WAS NOT DUE TO A MALFUNCTION OF THE DEVICE. THIS EVENT WAS REPORTED IN ERROR.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: DESPITE OUR ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO RESPONSE OR SAMPLE FOR EVALUATION WAS RECEIVED FROM THE HEALTH-CARE PROVIDER. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    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, THE DEVICE WAS EXPLANTED AT IMPLANT DUE TO UNKNOWN REASONS.

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED IN ERROR. THROUGH FOLLOW-UP WITH THE HEALTHCARE PROVIDER IT WAS LEARNED THAT THE EXPLANT WAS DUE TO ABNORMAL SHAPE OF TRICUSPID ANNULUS RELATED TO THE PATIENT'S CONGENITAL HEART CONDITION, NOT SUITABLE FOR RING ANNULOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 R-09L2696

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization| R