BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMR ETLOGIX ANNUPLASTY RING

    MDR report key: 2060256 · Received April 15, 2011

    Report

    Report Number
    2015691-2011-15238
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    December 10, 2010
    Report Date
    March 5, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. 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, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED ON THE SAME DAY OF SURGERY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO S.A.M. AND INSUFFICIENCY NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AFTER WEANING THE PATIENT OFF CARDIOPULMONARY BYPASS (CPB). ACCORDING TO THE OPERATIVE REPORT, THE PATIENT PRESENTED WITH P2 MITRAL VALVE PROLAPSE WITH 4+ INSUFFICIENCY. CPB WAS INSTITUTED AND THE EDWARDS ANNULOPLASTY RING WAS IMPLANTED. THE VALVE WAS TESTED WITH SALINE AND FOUND TO BE COMPLETELY COMPETENT. THE PATIENT WAS WEANED FROM CPB WITHOUT DIFFICULTY AND TEE REVEALED THE REPAIRED NATIVE MITRAL VALVE TO HAVE A SIGNIFICANT AMOUNT OF SYSTOLIC ANTERIOR MOTION AND SEVERE INSUFFICIENCY. THE PATIENT WAS PLACED BACK ON CPB, THE RING WAS REMOVED, AND THE VALVE WAS ONCE AGAIN TESTED AND APPEARED COMPLETELY COMPETENT. THE PATIENT WAS AGAIN WEANED FROM CPB AND THIS TIME THERE WAS ONLY MILD INSUFFICIENCY, MUCH LESS THAT WHAT WAS NOTED PREOPERATIVELY. THERE WERE NO COMPLICATIONS WITH THE PROCEDURE. FURTHERMORE, (PER THE HEALTH-CARE PROVIDER) THE REASON FOR EXPLANTING THE RING WAS PATIENT RELATED AND NOT DUE TO A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMR ETLOGIX ANNUPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4100 R-09D0704

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention