BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 2080954 · Received May 8, 2011

    Report

    Report Number
    2015691-2011-15489
    Event Type
    Injury
    Date Received
    May 8, 2011
    Date of Event
    December 22, 2010
    Report Date
    April 9, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: A RESPONSE WAS RECEIVED FROM THE SURGEON THAT INDICATED THE DEVICE WAS EXPLANTED DUE TO A FAILED RING REPAIR DUE TO PATIENT RELATED FACTORS. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION BY THE SURGEON. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE HOSPITAL. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS.

    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, THE ANNULOPLASTY RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF 16 DAYS (0.53 MONTHS) AND REPLACED BY A VALVE. A RESPONSE WAS RECEIVED FROM THE SURGEON INDICATING THAT THIS EXPLANT WAS NOT DUE TO A MALFUNCTION OF THE DEVICE AS IT WAS PATIENT RELATED AND INDICATED IT WAS DUE TO AN UNSUCCESSFUL RING REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 10K222

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R