BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMR ETLOGIX ANNUPLASTY RING

    MDR report key: 2061683 · Received April 18, 2011

    Report

    Report Number
    2015691-2011-15254
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    December 27, 2010
    Report Date
    March 21, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 AFTER AN IMPLANT DURATION OF APPROXIMATELY 3-1/2 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO MITRAL VALVE ENDOCARDITIS. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT HAD MITRAL VALVE REPAIR IN (B)(6) 2010 FOR MITRAL INSUFFICIENCY. POSTOPERATIVELY, SHE HAD AN APPARENT STROKE WITH SIGNIFICANT EXPRESSIVE APHASIA. SHE RECOVERED FROM THIS LARGELY. UNFORTUNATELY, SHE ALSO DEVELOPED URINARY TRACT INFECTIONS AND REQUIRED ANTIBIOTIC TREATMENT. IN NOVEMBER SHE WAS ADMITTED TO THE HOSPITAL WITH A LOW-GRADE FEVER, AND WAS FOUND TO HAVE A SIGNIFICANT MITRAL VALVE MURMUR. ECHOCARDIOGRAPHY DEMONSTRATED NEW VEGETATION ON THE MITRAL VALVE. BLOOD CULTURES WERE INITIALLY POSITIVE AND SHE WAS TREATED WITH IV ANTIBIOTICS. SHE WAS GIVEN TIME FOR RECUPERATION AND STRENGTHENING, AND DURING THIS INTERVAL HAD A FALL INJURING A LEFT RIB AND HAD A SPLENIC HEMATOMA AND/OR INFARCT. THIS LATER BECAME INFECTED AND DURING HER RECOVERY SHE HAD TO HAVE AN URGENT SPLENECTOMY FOR WHAT WAS THOUGHT A SPLENIC ABSCESS. UPON RE-EVALUATION, IT WAS DETERMINED NOT BE STOKE BUT A TIA. SUBSEQUENT EVALUATION DEMONSTRATED THE SEVERITY OF THE LEFT INTERNAL CAROTID STENOSIS AT GREATER THAN 95%, AND IT WAS FELT TO BE A HYPOPERFUSION CEREBRAL ISCHEMIC INCIDENT. IT WAS DECIDED PROCEED WITH MITRAL VALVE REPLACEMENT. UPON INSPECTION THE MITRAL VALVE RING WAS FOUND TO BE INTACT. ON THE ANTERIOR LEAFLET OF THE MITRAL VALVE WAS A LARGE VEGETATION WITH DESTRUCTION OF THE VALVULAR PORTION OF THE ANTERIOR LEAFLET NEAR THE ANNULUS. THE VALVE WAS REMOVED AND AN EDWARDS BIOPROSTHETIC VALVE WAS IMPLANTED. ECHOCARDIOGRAPHY AT THE END OF THE OPERATION DEMONSTRATED MITRAL VALVE PROSTHESIS WELL SEATED WITHOUT PERIVALVULAR LEAK. 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-10D0778

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention