BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT

    MDR report key: 2060383 · Received April 15, 2011

    Report

    Report Number
    2015691-2011-15244
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    July 16, 2008
    Report Date
    March 16, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K980487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 9 MONTHS DUE TO MITRAL REGURGITATION. ACCORDING TO THE OPERATIVE REPORT, THE RING WAS INITIALLY PLACED FOR MITRAL VALVE ENDOCARDITIS. THE PATIENT PRESENTED WITH MITRAL REGURGITATION, AND THEREFORE, WAS REFERRED FOR RE-DO MITRAL VALVE REPAIR. THE MITRAL VALVE ANTERIOR LEAFLET WAS NORMAL APPEARING EXCEPT FOR SOME THICKENING. THERE WAS NO EVIDENCE OF ENDOCARDITIS. THE RING WAS INTACT AND THE REPAIR WAS INTACT. IT WAS NOTED THAT SHE HAD DEVELOPED SOME FIBROSIS AND FORESHORTENING OF HER POSTERIOR LEAFLET. SHE HAD POOR COAPTATION OF 2 LEAFLETS. THE RING WAS REMOVED AND ANOTHER EDWARDS ANNULOPLASTY RING WAS PLACED. TRANSESOPHAGEAL ECHOCARDIOGRAM CONFIRMED EXCELLENT VALVE REPAIR. FURTHERMORE, THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4625 R-07H1590

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention