BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 2220871 · Received August 23, 2011

    Report

    Report Number
    2015691-2011-16088
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    June 2, 2011
    Report Date
    July 26, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K923367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NATIVE LEAFLET TORN AT ANNULOPLASTY RING ATTACHMENT. EVALUATION METHOD: DEVICE NOT AVAILABLE FOR RETURN PER PATHOLOGY DEPT. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THERE HAS BEEN NO OTHER RELATED ENDOCARDITIS/INFECTION REPORTS ON ANY DEVICES PROCESSED UNDER THE SAME STERILITY LOT OF THE SUBJECT RING. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    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 LEARNED THAT THE EDWARDS MITRAL ANNULOPLASTY RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 22 MONTHS. THE PATIENT'S NATIVE VALVE AND THE EDWARDS' RING WERE REPLACED WITH AN EDWARDS' PERICARDIAL VALVE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT EXPERIENCED INFECTIVE ENDOCARDITIS, SEVERE MITRAL REGURGITATION, AND SEVERE AORTIC INSUFFICIENCY. THE NATIVE AORTIC VALVE WAS ALSO EXPLANTED AND REPLACED DURING THE SAME SURGERY. OPERATIVE FINDINGS INDICATE, "THE MITRAL VALVE WAS SEVERELY ABNORMAL. THE P2 PORTION WAS TORN IN THE AREA WHERE THE PREVIOUS REPAIR HAD BEEN PERFORMED. THERE WAS AN EXOPHYTIC LESION ON THE POSTERIOR LEAFLET. THIS WAS EXCISED AND SUBMITTED FOR STAT GRAM STAIN THAT ULTIMATELY SHOWED GRAM-NEGATIVE COCCI, AND A SMALL NUMBER OF WHITE BLOOD CELLS. SUBSEQUENT CULTURES DAYS LATER WERE NEGATIVE AND FAILED TO GROW ANY ORGANISM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4600 R-09D0705

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R